Agenda

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Day 1
Monday, 2 November 2020
  • 0900 - 1100
    Opening Plenary Session
    Session Leaders
    Speakers
  • 1300 - 1430
    Advancing ATMPs in the City of Brotherly Love
    As interest in the Advanced Therapy Medicinal Product (ATMP) and cell and gene therapy market continues to grow at a rapid pace, novel processes are demanding facility and technology infrastructures unlike any that have previously existed. ATMPs could transform health for many patients, and all of us involved in the field, including those of us specializing in facility design, have a role to play in helping this new era of medicine to reach its potential. Please join us for a panel discussion centered around industry trends and challenges facing the ATMP industry and how Philadelphia is working together to achieve our end goal - to get products to patients.
    Session Leaders
    Speakers

    Sumit Verma

    Vice President, Commercial Manufacturing
    Iovance Biotherapeutics, Inc.
  • 1300 - 1430
    Pharma 4.0 Concepts & Cases
    The ISPE Pharma 4.0TM Operating Model was developed as a practical model for implementing a holistic approach for the digitalization of a pharmaceutical organization end-to-end. – While we are not there yet, some interesting case studies are available, showing the concepts are working and providing expected benefits. This session will overview how we can adjust our Pharmaceutical Quality Management System to embrace technology and increase data integrity, use our massive data stores for action by leveraging data analytics for Container System optimization and capping, and how facility management and building system support can increase productivity and reduce costs for pharmaceutical firms. For example, one core component of the Pharma 4.0TM Operating Model is the digitalization of the ICH Q10 Pharmaceutical Quality System (PQS), which is enabled by a Data Integrity by Design approach and a clear definition of Process Maps and Data Flows. Having this in place, data analytics will help to improve quality, performance and robustness of the processes and help to prevent drug shortages for the benefit of the patient.
    Session Leaders
    Speakers
    Presentation Information
    [Big Data Analytics for Parenteral Container System Optimization and Pharmaceutical Capping Processes] This topic directly addresses Pharma 4.0, and illustrates a process for integrating CCS component data directly into manufacturing to optimize capping in order to maintain both CCI and visual acceptance. The content to be presented is a description of the process feedback loop which can be utilized to optimize capping and sealing. It will then shift focus to what West Pharmaceutical Services can already provide as part of that feedback loop, in particular how raw component data can be combined with a simple capping model to more fully investigate vial CCS components before they are selected. As a result of this presentation, participants will: 1.) Understand how a process feedback loop incorporating supplier component data can be used to optimize capping and sealing within the context of Pharma 4.0. 2.) See how to use comprehensive stack-up analyses to predict rates of failure based on raw component dimensional data. 3.) Tie raw component quality data into a simple capping model to evaluate specific process parameters without the need for expensive and iterative trials. This will shorten product development timelines. || [Trimming the IT Quality Management System to Do More in Pharma 4.0] Review on the Quality management System (QMS) initiative that was completed with less than $40,000 budget, resulting in over $1.8 million annual ROI, this overview addresses the current problem in Pharma IT (and subsequently the rest of the company) that our current processes have inflated beyond capabilities, which has caused innovation to be bottle necked into a historical system. Using our case study to show this doesn't require massive upfront investment but instead relies on its people and the reduction in documentation that allows for more to get accomplished. The path will include the approach taken by CSL starting in 2017 and address the lessons learned from the initiative to help other companies transition faster. Additionally, it will show how the QMS can become more flexible by allowing different methodologies (agile/waterfall) and different areas to store information (electronic/paper) to digitize information. The takeaways: 1. Understand how to use existing employees to adjust the QMS for the future of pharma 4.0, and what that adjustment can look like. 2. Known common pitfalls to avoid during the transition 3. . Learn how to work in digital strategies that allow agile and digitization to fully develop and perform inside pharma IT. || [Leveraging Pharma 4.0 Solutions in Facilities Management] Pharmaceutical companies have outsourced many elements of facilities management and services (FM & S) in the last decade to drive cost savings. One way to break the constant tension between minimizing FM costs by cutting service is by introducing innovation in this equation. The best application of innovation in FM & S is by employing a subset of Pharma 4.0 technologies. This presentation will detail Pharma 4.0 tools and solutions that specifically apply to FM, including case studies, business cases, and lessons learned. Participants will learn how Pharma 4.0 solutions can be expanded beyond traditonal manufacturing operations to drive further savings for their companies.
  • 1300 - 1430
    Innovation Ecosystems
    In a world of accelerating change, companies can no longer rely of top down strategies to adapt and innovate. Rather, the ability to harness the wisdom of the crowd is becoming central to drive incremental and disruptive innovations across discovery, development, manufacturing, and supply. Yet the best practices to harness the talents of the masses remain under-developed. This session will present different viewpoints on how to inspire and challenge, crowdsource and connect ideas, sponsor, and fund projects through progressive stages, and ultimately drive results from the innovators that permeate throughout modern corporations. As a result of the session, participants can expect to take away best practices for setting up their own innovation ecosystem, or better engaging and enhancing the ecosystem in which they already find themselves.
  • 1300 - 1430
    Process Technology
    This session will focus on technologies associated with the future state of manufacturing. Critical to successful process scale-up is defining process capability and robustness including integration of data analytics, in silico modeling, and process control. The presentations in this session cover a wide variety of technologies from spray dried dispersion, to small-scale bioreactors to the use of single use technologies. The benefits of using these tools to evaluate the technologies and how this leads to successful scale-up and implementation will be presented.
    Speakers
    Presentation Information
    [Use of CFD to Evaluate Spray Drying Scale-up Approaches] Spray dried dispersions (SDDs) play an important role in enhancing oral bioavailability of drug substances. Matching performance and physical characteristics of SDDs produced at pilot scale to those at commercial scale poses on-going challenges to the industry. Understanding evaporation kinetics and transport phenomena occurring in a spray drying chamber is critical to understanding how to match SDD characteristics across scales. CFD modeling of spray drying systems is commonly used to support this understanding. In this study, solvent droplet drying kinetics was selected as a figure of merit for scaling. A Lagrangian approach to post-processing CFD models was used. A sensitivity analysis of variables and their connection to evaporation kinetics was conducted. Analysis was performed across scales to identify new approaches to matching evaporation rates and isolate critical parameters for manipulation of SDD properties. Factors evaluated include typically cited scaling parameters and transport phenomena driving forces (T_out, Liquid:Gas ratio, droplet size, relative saturation). Insights into the role of spray characteristics such as droplet velocity, size and distribution were obtained and relative importance assessed. When studying multi-solvent evaporation, late-stage evaporative behavior with respect to relative concentration of the two solvents was noted. Evaporation time scale and droplet trajectory length were also explored. || [Single Use: a Global Solution or Global Impact?] The development of single-use technologies in the biotech industry brought with it seemingly numerous advantages – no cleaning, no detergents, and no complex qualification. The industry quickly adopted single-use technology to reduce the risk of cross contamination and simplify validation procedures. However, since the 1990s, there has been little discussion around the negative impacts due to the switch from stainless steel to single-use. To provide the industry a more complete understanding of the impacts of single-use technology vs. stainless steel, this presentation will investigate all aspects of single-use which have been previously overlooked, including safe handling of materials, disposal procedures, warehouse spacing, and overall environmental effects. Objectives: • Investigate the life cycle of single-use technology from beginning to end • Educate clients on safe handling procedures • Prepare clients for upfront costs usually missed with warehouse spacing • Consider the cost of adding additional CO2 emissions from incineration The key take-home messages from the presentation are: --How clients can evaluate their procedures to understand whether single-use is the best approach for their facilities || [Enhanced PID Control of Bioreactors using a Disturbance Rejection Approach] Achieving robust DO control through oxygen enrichment, while minimizing foam generation and reducing pH perturbation, is a classic bioreactor control problem that has become of increased concern due to an increasing demand for processes with higher cell densities and associated higher oxygen demand. To this end, a direct synthesis and distribution rejection (DS-d) approach was used to produce scheduled PI loop tuning control parameters for DO control for two scales of bioreactor scale-down models (250mL and 3L). This work demonstrates that DS-d is a reliable method for producing scheduled DO loop tuning control parameters over a range of projected gas flow rates that yield minimum DO fluctuations while minimizing foam generation and pH perturbation. As a result of this presentation, participants will understand why DS-d is a desirable method to determine DO control parameters and the importance of balancing gas addition, foam generation, and pH control on bioreactor scale-down models. The greater impact of this work is that this strategy allows for the successful and more automated operation of small-scale bioreactors to generate high-throughput data over a range of operating conditions and parameters.
  • 1300 - 1430
    The Importance of Quality Management Maturity
    FDA introduced interest in quality management system maturity and a rating system of maturity of manufacturing facilities in their 2019 Drug Shortages report. Experienced industry, FDA and academic speakers will present on 1) The background, status and content of ISPE’s industry-for-industry quality maturity framework. This framework has been developed over the past 3 years and evolved from ISPE’s research in response to FDA Quality Metrics draft guidances, and its work to issue the Cultural Excellence report. This program is scheduled to deliver its first module in assessment and potential improvement of CAPA maturity; 2) FDA’s journey to assessing quality management maturity; 3) An academic perspective on how to assess quality maturity
    Session Leaders
    Speakers

    Thomas Friedli, PhD

    Director, Institute of Technology Management
    University of St. Gallen (Switzerland)
    Presentation Information
    [Quality System Maturity from a Data Perspective and the Maturity - Performance Link] Does Quality System Maturity really matter? The presentation shows the link from Quality System Maturity to Plant Performance and explains the newly developed St.Gallen ISPE APQ Pre- and Post Assessment. || [Advancing Pharmaceutical Quality – ISPE’s Quality Management Framework] The presentation will summarize the ISPE Advancing Pharmaceutical Quality (APQ) Assess, Aspire, Act and Advance (AAAA) Framework by: • Highlighting the goals of this industry-for-industry program • Showing how it is based on ICH Q10 Pharmaceutical Quality elements • Explaining how ISPE’s AAAA Framework is enhanced by an optional pre-assessment and post-action quantitative benchmarking developed by St Gallen • Giving some detail of the Corrective Action Preventive Action (CAPA) element • Providing learnings from a pilot study • Indicating how the CAPA element will be delivered • Showing how other ICH Q10 elements are being developed • Providing a summary of supporting ISPE Cultural Excellence activity • Concluding with the importance to ISPE of this program
  • 1300 - 1430
    Improving Vaccine Delivery to the Developing World
    Current delivery of liquid injectable vaccines to the developing world is currently based on the multi-dose vial. Investigations have shown that the cost per delivered dose with multi-dose vials is significantly higher than the initial cost per dose at the factory; wastage through loss of unused doses, glass breakage product loss and temperature excursions all add to the final cost per dose. Blow/Fill/Seal (BFS) advanced aseptic technology has been investigated for the application of single dose vaccine packaging. Ongoing work has shown that the technology is viable for producing single dose primary packaging for Live Attenuated and inactive vaccines. The work includes container and device designs for oral and injectable vaccines, product stability studies, cost comparison between packing technologies, and developing world human factor studies to test the container design and function. This presentation will introduce participants to BFS technology and its application to cold chain products, single dose container designs for oral and injectable vaccines, and the challenges around filling adjuvants.
    Session Leaders
    Placeholder Person Graphic

    Tim Kram

    General Manager-North America
    Rommelag USA
    Speakers
    Placeholder Person Graphic

    Tim Kram

    General Manager-North America
    Rommelag USA
    Presentation Information
    [Suitability of Blow-fill-seal Containers for Vaccines] Scott Knackstedt is a commercialization officer with PATH’s Medical Devices and Health Technologies program: Access to vaccines and pharmaceuticals in low-resource settings can be improved through delivery devices that improve safety and ease of use and enable alternative delivery scenarios such as self-administration and outreach. However, many packaging technologies, such as the glass prefilled syringes commonly used in high-income country settings, are expensive and lack features that are necessary for programmatic suitability in low- and middle-income countries, such as autodisable mechanisms and compact volumes. Blow-fill-seal technology offers the potential for low-cost, high volume production of vaccines and essential medicines, with a wide variety of container designs to enhance usability and reduce storage volumes. PATH has conducted evaluations of usability, acceptability, and programmatic fit of blow-fill-seal containers for vaccine delivery in multiple countries, developed cost models to assess the overall health system cost impact, and created Target Product Profiles to inform development. As a result of this presentation participants will understand the key attributes of packaging and delivery technologies for suitability for use in low-resource settings and factors impacting costs to health systems of introducing products in blow-fill-seal containers rather than glass vials. || [Improving Vaccine Delivery to the Developing World ] Current delivery of liquid injectable vaccines to the developing world is currently based on the multi-dose vial. Investigations have shown that the cost per delivered dose with multi-dose vials is significantly higher than the initial cost per dose at the factory; wastage through loss of unused doses, glass breakage product loss and temperature excursions all add to the final cost per dose. Blow/Fill/Seal (BFS) advanced aseptic technology has been investigated for the application of single dose vaccine packaging. Ongoing work has shown that the technology is viable for producing single dose primary packaging for Live Attenuated and inactive vaccines. The work includes container and device designs for oral and injectable vaccines, product stability studies, cost comparison between packing technologies, and developing world human factor studies to test the container design and function. This presentation will introduce participants to BFS technology and its application to cold chain products, single dose container designs for oral and injectable vaccines, and the challenges around filling adjuvants.
Day 1 - Day 5
2 November - 6 November 2020
Day 2
Tuesday, 3 November 2020
  • 1030 - 1200
    FOYA Category Winner Presentations
    Get an in-depth look at the latest, state-of-the-art developments being implemented by ISPE’s 2020 Facility of the Year Awards (FOYA) Category Winners. Hear from the project teams themselves as they share the technical story of their project and learn how excellence was delivered via innovative thinking.
    Session Leaders
    Speakers
    Presentation Information
    [Attachment Inhibitor Project] Presentation of one FOYA winner for Social Impact Category
  • 1230 - 1400
    FOYA Category Winner Presentations
    Get an in-depth look at the latest, state-of-the-art developments being implemented by ISPE’s 2020 Facility of the Year Awards (FOYA) Category Winners. Hear from the project teams themselves as they share the technical story of their project and learn how excellence was delivered via innovative thinking.
    Session Leaders
    Speakers
    Placeholder Person Graphic

    Matthew L. Depola

    Sr. Director, Engineering and Facilities
    United Therapeutics Corporation
Day 3
Wednesday, 4 November 2020
  • 0900 - 1100
    Global Regulatory Town Hall - The Impact of a Pandemic on Harmonization and Convergence
    The impact of the current pandemic will have far-reaching effects on global regulations, inspections, and related efforts toward regulatory harmonization and convergence. The discussion during this year’s Town Hall will center around COVID-19-related implications for global regulatory alignment. The pandemic has shed new light on the need for developing internationally harmonized standards and standards convergence to facilitate greater coordination and oversight of medical products. The current environment has not only exacerbated existing weaknesses in the supply chain, but also has let to postponed inspections, increased scrutiny of products shipped internationally, and highlighted inconsistencies in the regulatory processes from agency to agency. Representatives from USFDA, MHRA, ANVISA, WHO, ANSM, EMA, PIC/S, and Health Canada have been invited to join the live discussion.
    Session Leaders
  • 1300 - 1430
    Agile Project Delivery-Cell & Gene Therapy Facilities
    Pharmaceutical companies are now investing heavily in R&D to develop cell and gene therapies targeting previously incurable diseases, with the FDA anticipating more than 200 investigational new drug applications per year. Commercial growth in this sector will require substantial investment in new research and manufacturing facilities, with an emphasis on speed to market, flexibility, cost, and innovation. This session will review best practices in developing an agile engineering project delivery model to support these goals, focusing on the unique project management challenges in delivering projects for the cell and gene therapy sector. We will also discuss how innovations in robotics, engineering design, and modular construction can be leveraged to accelerate delivery and improve safety, quality, and reliability.
    Session Leaders
    Speakers
    Presentation Information
    [Project Management Best Practices in Delivering Cell and Gene Therapy Facilities] Pharmaceutical companies are now investing heavily in R&D to develop cell and gene therapies targeting previously incurable diseases, with the FDA anticipating more than 200 investigational new drug applications per year. Commercial growth in this sector will require substantial investment in new research and manufacturing facilities, with an emphasis on speed to market, flexibility, cost, and innovation. This session will review best practices in developing an agile engineering project delivery model to support these goals, focusing on the unique project management challenges in delivering projects for the cell and gene therapy sector. We will also discuss how innovations in robotics, engineering design, and modular construction can be leveraged to accelerate delivery and improve safety, quality, and reliability. Key learning objectives: - Understand the unique design differences and challenges in delivering cell and gene therapy facilities - Apply critical project management processes and tools to drive performance and target value delivery - Leverage innovative technologies in design and construction || [Project Management Best Practices in Delivering Cell and Gene Therapy Facilities] Pharmaceutical companies are now investing heavily in R&D to develop cell and gene therapies targeting previously incurable diseases, with the FDA anticipating more than 200 investigational new drug applications per year. Commercial growth in this sector will require substantial investment in new research and manufacturing facilities, with an emphasis on speed to market, flexibility, cost, and innovation. This session will review best practices in developing an agile engineering project delivery model to support these goals, focusing on the unique project management challenges in delivering projects for the cell and gene therapy sector. We will also discuss how innovations in robotics, engineering design, and modular construction can be leveraged to accelerate delivery and improve safety, quality, and reliability. Key learning objectives: - Understand the unique design differences and challenges in delivering cell and gene therapy facilities - Apply critical project management processes and tools to drive performance and target value delivery - Leverage innovative technologies in design and construction
  • 1300 - 1430
    GAMP® Data Integrity by Design (Part 1)
    Data Integrity by Design is a critical-to-quality initiative for GxP organizations because their business model is driving changes in technology requirements i.e. the globalization of business needs the ability to manage data globally. Additionally, there is an urgent need for fully electronic records replacing manual tasks to eliminate process steps that are potentially subject to human error and therefore comprise points of higher data integrity risk. Essential considerations for DI by Design include 1) A high-level retention strategy, establishing early in the business process design phase how regulated records will be managed and maintained throughout the mandated retention period, and from this the requirements for the supporting computerized systems and electronic archives can be derived; 2) An approach for addressing systems which once would have had a simple analogue display but now create electronic records in addition to the display; examples include pH meters, filter integrity testers, portable particle counters etc. The equipment vendors have added electronic records as part of product evolution but created additional data integrity risks which must be managed; 3) A validation approach for data integrity technical controls, demonstrating Computer Software Assurance principles as an evolution of the Risk-Based Approach.
    Session Leaders
    Speakers
    Presentation Information
    [Complex Simple Devices] There is an increased focus on data integrity controls for Complex Simple Systems (e.g.pH meters, filter integrity testers, balances, etc.) as they have become more advanced over the past few years. This presentation will discuss some of the identified risks and possible mitigations. || [Validation Approach for Data Integrity Technical Controls] need to get from Senthil || [High Level Retention Strategy] Data Integrity by Design is a critical-to-quality initiative for GxP organizations because their business model is driving changes in technology requirements i.e. the globalization of business needs the ability to manage data globally. Additionally, there is an urgent need for fully electronic records replacing manual tasks to eliminate process steps that are potentially subject to human error and therefore comprise higher points of data integrity risk. The session includes: 1) an introduction to the need for a Retention Strategy; 2) an approach for addressing systems that once would have had a simple analog display but now create electronic records (e.g. pH meters, filter integrity testers etc.; 3) The need for Vendor 2.0, in support of data integrity by design; and 4) A validation approach for data integrity technical controls, demonstrating Computer Software Assurance principles as a reinforcement of the Risk-Based Approach.
  • 1300 - 1430
    Driving Business Outcomes- Data Analytics Innovation
    Many industries have demonstrated enabling technologies, with a proven track record of providing quality products at a fraction of the cost and manufacturing space. One of the most exciting pharma frontiers is innovation related to meeting the emerging needs of patients - how to supply batches quickly and with consistent quality. This includes rapid evolution to meet these ever-changing supply chain requirements. There is growing evidence to support how continuous manufacturing, for example, offers batch size flexibility, streamlined development and smaller manufacturing footprints — all without the old challenges of scaling. This lessened angst around scale-up means we can accelerate the timeframe from development to commercial launch. For example, industries like food and beverage and chemicals, have reaped the benefits of utilizing PAT coupled with data analytics applications; effectively making the right process and product measurements, storing this valuable data, and then accessing it for near real-time decision making by subject matter experts (SMEs). Speakers will present their unique case studies highlighting examples like using PAT applications and the data science approaches utilized for fault detection and predictive maintenance. Participants will receive real-world knowledge of digital transformation projects focused on maximizing the use of manufacturing system data.
    Session Leaders
    Speakers
    Presentation Information
    [Using Data Analytics to Drive Business Outcomes in Manufacturing Successfully] Companies invest significant time and resources in the development of products for their patients, generating significant data assets in the process. These data assets are valuable and should be fully leveraged to drive improvements in product quality, process robustness, and speed to market. Whether utilizing batch or continuous manufacturing, an agile data analytics strategy enables more efficient identification of data trends and drives deeper understanding of process variability at the speed of manufacturing today. The presentation will include real-world examples highlighting opportunities to ensure robust process operation during commercial manufacture. Key elements include the importance of 1) enabling rapid data capture and access, 2) coupling the subject matter expert directly with the data, and 3) becoming an analytics-driven organization. Utilized by managers, scientists and engineers, a good analytics methodology will support the goal of getting the most out of existing data assets, while facilitating knowledge sharing and collaboration across the organization. || [Lower the Barrier by Raising the Bar: Deployment of Data Analytics To Build an Infrastructure to Support Continuous Manufacturing] The barrier for leveraging digital analytics can be high at times. Matching a business need to the right application can often seem like an endless merry-go-round. Even though scientists and engineers exclusively use analytics to solve technical problems, reduce risk, and develop a strategy, they are naturally siloed by the nature of the business need and the larger business can miss the rewards. This talk will focus on the strategy being employed and the applications that are deployed at Merck to leverage data analytics in the area of continuous manufacturing. Examples will cover digital analytic use cases for Technology Transfer, Process lab activities, and Technology development. || [Analytics Keys to Pharmaceutical Manufacturing Gateways] Opportunities to advance and expedite the pharmaceutical pipeline exist at every stage from target disease identification through delivery of medicine to patients. This presentation will discuss opportunities for optimization at each phase from product development through regular commercial production for oral solid dose medicines manufactured on a continuous manufacturing line. Cases will be made for leveraging data for both business tools and direct GMP decisions. Historical material property data may be utilized to reduce the number of experiments required to optimize process parameters. Process models built for both batch and continuous equipment can lead to a reduction in the experimental runs required for tech transfer. Integrated process analytical technology (PAT), allows for product quality assessment to be made during manufacture, reducing or eliminating the need for post-manufacture testing. Monitoring of process and equipment data allows for early anomaly detection to prevent or reduce impact of equipment failures. Finally, implementation of continuous process verification (CPV) trending capabilities shifts time spent from data gathering to data analysis. Time savings throughout each of these steps allows every function to work smarter and faster, expediting the delivery of high-quality medicines to patients.
  • 1300 - 1430
    Process Optimization and Technology Transfer
    This session will focus on process understanding and process control in the bio-pharmaceutical industry and how it applies to different stages of the product lifecycle. It will provide insight into how expert knowledge combined with predictive and prescriptive analytics enable (i) PAI readiness and new product approval; (ii) commercial manufacturing process robustness; and (iii) complex, multi-site process and analytical method transfers. The presentations will follow the critical sequence and steps of the product lifecycle and highlight the advances made in the use of data analytics.
    Session Leaders

    Philippe Cini, PhD

    Group Vice President - Turesol Leader
    Turesol - Staffing Division of Tunnell Consulting
    Speakers

    Philippe Cini, PhD

    Group Vice President - Turesol Leader
    Turesol - Staffing Division of Tunnell Consulting
    Presentation Information
    [Shifting the Focus to Predictive and Prescriptive Analytics] The pharmaceutical industry has invested into equipment and sensors to provide a data-rich environment for analytics. Historically, most of the analytics focus has been on diagnostic root cause analyses or description of historical production. In order to optimize the production process and fully leverage the available data, the industry should shift the analytics perspective towards predictive and prescriptive analytics to actively prevent unplanned downtime and deviations. An ideal production process will leverage the process knowledge of the engineers, the observations from the operators, and the machine learning algorithms from data scientists to proactively improve quality, reduce cycle times, and maintain consistent operation. This presentation will address key opportunities and challenges in the pharmaceutical sector to apply advanced analytics. Process optimization case studies will be provided as examples in leveraging Process Analytical Technologies (PAT), applying predictive maintenance strategies, and operationalizing machine learning models, while facilitating knowledge sharing and collaboration throughout the organization. || [A Complex Tech Transfer Case Study] This presentation will showcase a complex technology transfer of two versions (intravenous and subcutaneous) of a monoclonal antibody. The two molecule versions represented different technology transfer cases. One molecule version represented a site transfer, requiring major equipment modifications at the receiving site. The second molecule version represented a generation change and site transfer. The second molecule version built upon the first molecule version qualification, as most of the process steps were equal. The transfer involved three-way partnerships of product owner and process developer (as tech transfer donor) and a contract manufacturing organization (as tech transfer receiver). This presentation will highlight approaches used to manage this complex tech transfer involving two molecule versions, three-way partnerships, two manufacturing sites, and five analytical testing sites. Some of the challenges phased by the team to manage the process validation lifecycle, including ongoing submissions for drug substance manufacturing and update to the control system will also be highlighted. || [Process Understanding & Control – Preparing for a Successful PLI] A case study of how to establish process understanding and process control in the challenging situation of a new biological product that uses a disruptive, never approved before, manufacturing technology will be presented. The approach is risk-based. It combines in a systematic way the use of expert knowledge, statistical capabilities and advanced statistical data mining. The data used consists primarily of historical, development data that was not originally intended for statistical analysis; hence saving precious time and equipment resources in the typical race to product approval. The benefits of such an approach are multiple and of great significance: (i) provides the ability to define and document the manufacturing and analytical design spaces, (ii) justifies the proposed product and in-process specifications and (iii) defines the appropriate levels of control using an exhaustive, systematic, multi-disciplinary, historical data-driven approach that an FDA inspector can easily understand; a requirement that is so critically important for a successful Pre-Licensing Inspection.
  • 1300 - 1430
    Worldwide State of Quality-Assessment of 1000+ Sites
    St.Gallen is currently executing the FDA funded project "Quality Benchmarking Study" together with Dun & Bradstreet. In this research project, a shortened OPEX & Quality benchmarking has been developed. it contains a scientifically derived subset of the legacy full St.Gallen Benchmarking and selected Enablers, that have been proven as most meaningful for surrogating overall system’s stability and performance. The assessment is currently conducted in the pharmaceutical industry and will allow access to operational data of 1000+ drug manufacturing sites worldwide. The session starts describing the process of scientifically conceptualizing an assessment that requires a limited set of datapoints but is still meaningful to surrogate overall production & quality system's performance. Afterwards, results from investigating sites worldwide are presented. The session concludes with enhanced analytics on the gathered data, highlighting differences in the level of quality performance across technologies, site types and locations. Relations between certain quality KPIs as well as enablers and the overall state of quality are shown. 1. Scientific methodology to derive an OPEX & quality assessment. 2. Most meaningful quality metrics to assess the production & quality system. 3. Current state of quality performance across different site types, locations & technology platforms.
    Session Leaders

    Thomas Friedli, PhD

    Director, Institute of Technology Management
    University of St. Gallen (Switzerland)
    Speakers
    Placeholder Person Graphic

    Marten Ritz

    Research Associate & Head of Operational Excellence
    University of St.Gallen

    Thomas Friedli, PhD

    Director, Institute of Technology Management
    University of St. Gallen (Switzerland)
    Presentation Information
    [Quality Mgmt Maturity - Analytics & Preliminary Results] The presentation will release preliminary results of the 2020 Quality Benchmarking Study "A Global Initiative to Baseline Pharmaceutical Quality Management". Differences in operational performance and quality management maturity across pharmaceutical manufacturing establishment will be presented, patterns between different manufacturing technologies and regions identified. || [Developing scientifically an Assessment for a Global Quality Study - Methodology, Deployment and Outcome] The presentation explains how a set of KPIs as well as Quality Enablers have been scientifically developed to cinduct a FDA-sponsored global quality study. Learnings from the deployment are presented as well as the outcome regarding participation.
  • 1300 - 1430
    Rapid Biological Facility Development
    Vaccine and drug products that are being supplied to the developing world can take advantage of BFS technology that has been developed for high efficiency and quality, and low-cost drug production. In order to test these biological products, it was necessary to have a facility that would allow safe product testing. Rommelag CMO (Zell, Switzerland) installed the first BFS technology into a BSL-2 rated facility to provide a place to test biological products in 2012. The high automation level, high aseptic assurance, low intrinsic and extrinsic particle load found in the containers has increased interest in BFS technology for vaccines and other biological products. This case study will cover the various vaccines and biotech products that have been tested in this special facility. Topics covered will be plastic material compatibility, special procedures necessary for a multi-product facility, and the ability to scale BFS applications to very and fast production likes with pandemic applications.
    Speakers
Day 4
Thursday, 5 November 2020
  • 0800 - 0900
    ISPE Member Meeting
  • 0930 - 1100
    Integrated C&Q Applied on a Turn-Key Project
    GSK (Owner), CRB (Design & Build), and CAI (C&Q) partnered from project detailed design stage to deliver a ~$100M “Turn-key” solution capital project, grounded in the principles of Integrated C&Q as defined in the ISPE Baseline Guide 5 2nd Edition. This will be a joint presentation from the respective project leads detailing one of the first large capital projects to adopt the new Baseline Guide, and will cover the project approach to C&Q, practical lessons learned, wins and pitfalls. A number of key project decisions, and their cascading impacts throughout the project lifecycle will be covered, with particular emphasis on the importance of deliberate and timely user requirement definition, early alignment on project approach, and aggressive implementation of engineering quality process.
    Presentation Information
    [Project Debrief: Integrated C&Q Applied on a Turn-Key Project] GSK (Owner), CRB (Design & Build), and CAI (C&Q) partnered from project detailed design stage to deliver a ~$100M “Turn-key” solution capital project, grounded in the principles of Integrated C&Q as defined in the ISPE Baseline Guide 5 2nd Edition. This will be a joint presentation from the respective project leads detailing one of the first large capital projects to adopt the new Baseline Guide, and will cover the project approach to C&Q, practical lessons learned, wins and pitfalls. A number of key project decisions, and their cascading impacts throughout the project lifecycle will be covered, with particular emphasis on the importance of deliberate and timely user requirement definition, early alignment on project approach, and aggressive implementation of engineering quality process. The presentation will be followed by an extended (~30 minute) Q&A session.
  • 0930 - 1100
    GAMP® Data Integrity by Design (Part 2)
    With the large volume of data being generated there need to be metrics and business rules to detect potential issues to control the integrity of the data. With continued outsourcing there is also a significant need to manage the integrity of the vendor’s data that could affect the parent company’s products. Regulatory agencies are now starting to indicate the need to manage all electronic records over the entire retention period to assure that integrity was maintained back to the original raw data records. (Presentation 1) Clearly defined business rules and metrics derived from these rules will form an important foundation to efficiently detect potential data integrity problems during review for early intervention before they impact quality and safety. (Presentation 2) Without “Vendor 2.0” there cannot be Pharma 4.0: Applications in managing the integrity of the data generated at contract vendors poses a significant challenge that must be addressed if the industry wants to make Pharma 4.0 a reality. (Presentation 3) Practical approaches and strategies will be given for maintaining access, readability, and the Data Integrity principles in records created with legacy software packages that are no longer in production use including case studies.
    Session Leaders

    Robert Dillman

    Informatics Specialist-Data Integrity
    Eli Lilly and Company
    Speakers

    Robert Dillman

    Informatics Specialist-Data Integrity
    Eli Lilly and Company
    Presentation Information
    [Business Rules and Metrics Designed to Detect DI Problems] Clearly defined business rules and metrics derived from these rules will form an important foundation to efficiently detect potential data integrity problems during review for early intervention before they impact quality and safety.
  • 0930 - 1100
    Digital Twin
    Establishing a digital process model or digital twin, reduces development time and costs allowing for earlier new product launch. In development of these models we also define process cause and effects to better position for future process improvements, optimization, and repeatability. However, making digital twins is not without its challenges. Hear from three industry experts on how these tools are developed and used.
    Session Leaders
    Speakers
    Presentation Information
    [Digital Twin: End-to-end Performance & Compliance in Pharma] Speeding up the end to end process of taking something from R&D to commercial manufacturing is difficult in most industries. In the heavily regulated pharmaceutical industry, it is deeply difficult. Doing it at speed with a high level of certainty for certification seems impossible. Yet the challenge remains! Digital Twins are becoming a key focus for all pharma companies that are driving digital transformation projects, as they offer a new paradigm to drive this process with performance, traceability, and compliance – shortening the end to end time frame while capturing ALL of the information in each of the key stages and ensuring compliance with FDA 21CFR11 and all of the good practices from GLP, GCP, GMP, GDP to GPvP. This session is designed to help you to think and act differently with Digital Twins, showing the secret of how the various good practices can be embedded and used, as well as how to capture and leverage all data. The session will also show some of the ways that companies can attain significant ROI with digital twins, from designing and encoding the control strategy into the digital twin to methods of reliably estimating the minimum number of required PPQ batches. || [Nextgen Tech Transfers for Solids Drug Product with Modeling & PAT] Solid drug products are typically manufactured in large batches (several hundred kilos in size). We have created an integrated end to end approach for drug product process characterization which can not only reduce the number of full scale characterization batches but also lead to increased process understanding and subsequent reduction in risks during and prior to process characterization. It employs a combination of existing manufacturing process data, pilot scale process data, digital twins, sensors, and statistically designed experiments analyzed with multi-variate analysis. We will present the strategy for application of the tools. Reducing the number of full-scale batches has saved cost by reducing the cost of materials, by reducing the costs of manufacturing the experimental batches, reducing the cost of disposal of all of these non-salable experimental batches, and by reducing the cost and wasted associated with the testing of those experimental batches. In addition, it has eliminated the time required to make and test those experimental batches, enabling commercial products to launch sooner. The innovative tools that we have developed will be presented along with the innovative strategy to validate them. || [GSK’s Approach to Industry 4.0. with a Focus on Digital Process] GSK uses mechanistic modeling and semi-empirical relationships to build in-silico Product Design Tools and Digital Twins of our processes in development. These can then be used to lean experimental plans and at the same time increase fundamental understanding. GSK believes that a strong foundation in development is a prerequisite for manufacturing improvements such as simplification and digitization. Machine Learning and Artificial Intelligence are often hyped as necessary for Industry 4.0. There is some use for these techniques in development, but conditions often do not favor it. Data sets are usually too small and our understanding of physio chemical mechanisms favor more direct mechanistic approaches. At GSK our initial priority was to use digital design for continuous Drug Substance development. The benefits for Digital Design are greater for complex processes such as multiple telescoped reactions and unit operations. Also, our unit operation models for Drug Substance processes are more advanced. More recently we have moved to Digital Design of continuous Drug Product and batch Drug Substance. In this presentation we hope to communicate the current state of Industry 4.0 implementation at GSK and encourage discussions with others that have similar experiences.
  • 0930 - 1100
    Multi-Product ATMP Facilities for Future Flexibility
    The rapidly growing advanced therapy medicinal product (ATMP) market gives hope to people suffering from previously untreatable and rare diseases. But, to make that hope a reality, manufacturers must find a way to produce ATMPs quickly, efficiently and at scale. With companies now having a multitude of different product modes within their portfolio (mAb, cell-based therapies, viral vectors, novel technologies, etc), the need for a facility which can accommodate different process platforms is greater than ever before. This session will present several different future-facing product types and how to provide the best possibility for an effective and efficient multi-product facility. We will discuss the science and manufacturing considerations around how to make these products compatible (under one roof), how to potentially leverage synchronicity in shared resources for each production space, and ultimately explore the design that will make this flexible facility a reality. Achieve an appropriate scale, faster speed-to-market, lower costs, and manufacturing flexibility with a multi-product ATMP facility.
    Session Leaders
    Speakers
  • 0930 - 1100
    Combination Products Part 1: An Industry Perspective
    Combination Products technology and regulations are evolving globally. One consistent undercurrent in this dynamic regulatory environment is the drive for successful practices and control strategies throughout the combination product lifecycle. In this session we’ll discuss technical product solutions and case studies, as well as evolving global regulations from an industry perspective.
    Session Leaders
    Speakers

    Jörg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
  • 0930 - 1100
    Drug Shortages: Progress in a Challenging Year
    Following issue of the FDA Drug Shortages: Root Causes and Potential Solutions there has been renewed activity by Health Authorities (HA) globally as well as ISPE to the drug shortages issue, particularly with the need to respond to the COVID 19 pandemic. Experts from the front line will present their experiences. Outputs from the ISPE Drug Shortages team, which include: 1) an important publication describing the advantages of proactive communication with HAs, supported by case studies; 2) a Business Continuity plan, which summarizes actions for senior management to prepare proactively for potential drug shortages; 3) Experiences and learnings from the COVID-19 pandemic supply chain pressures; and 4) FDA perspectives, especially from their 2019 report and as a result of the COVID-19 pandemic. As a result of this session participants will gain 1) Experienced industry’s best practice to communication with HAs as well as how to develop a business continuity plan; 2) Learnings relevant to drug, device and hospital consumable shortages and strains in the supply chain during the COVID 19 pandemic; and 3) Opportunities to interact with FDA, industry and academic experts in a Q&A session and informally at the conference.
    Session Leaders
    Speakers
  • 1145 - 1315
    Project Execution for Challenging Times
    This session will highlight the challenges and demands that the Life Sciences are currently facing and what will become the New Normal for future project executions. The speakers will outline the most pressing issues and discuss ways forward for our Industry. This includes speeding up the project execution and ensuring manufacturing flexibility without compromising safety and quality.
    Speakers
    Placeholder Person Graphic

    Anton Enzinger

    Head of Technical Operations
    RED Engineering GmbH (VTU Group)
    Presentation Information
    [Paradigm Shift in the Execution of CAPEX Projects] The desire to get a grip on the ever increasing CAPEX investments, combined with the need for a speedy project realization and the necessity to unburden the client organization, require a profound rethinking in how future projects in the biopharma industry should be executed in future. In this presentation the following topics will be addressed and supported by an actual case study of an ongoing project with a bio-pharmaceutical MNC: - Execution strategies in the life sciences industry – How to address the specific need of the biopharma industry in mature as well as emerging markets - Design/Bid/Build versus the EPC open book approach, already established in the Food/ Nutrition and FMCG market space. We will discuss what the biopharma manufacturing can learn and copy smart for their project execution strategies - Procurement 4.0 – a holistic approach to build up your sustainable strategic project partners - Hybrid construction execution – employing the best construction method for impact and non-impact building areas and how to design the interfaces in order to have a smooth transition between the on- and offshore portion of the project. || [Beyond Flash Track - Facility Delivery in a Time of Crisis] We will soon be faced with the need to produce a billion doses of a novel vaccine, with potentially millions of people dying for each month of delay. We will need to innovate in our methods of delivery these new facilities and challenge all of our assumptions on what is possible. The presentation will explore potential ways to drastically reduce the timelines required to delivery new manufacturing facilities and open a conversation on how to remove barriers and get out of our own way. As a result of this presentation participants will start to explore potential ways to reduce schedule lead time and examine the trade offs involved with residual risk in a project versus the risk of not moving quickly. || [Speed up Clean Utilities Execution with Modularization] To reduce the time-to-market, the super skid approach with a maximum of prefabrication is already well established in the construction of process plants. However, different conditions and requirements exist for media systems and pipe racks, e.g.: - Maximum flexibility regarding changes during project development - Maximum flexibility regarding schedule changes, especially for on-site assembly - Minimum assembly time on site - Maximum possible separation of trades (especially stainless steel and steel) - Independent commissioning of utilities and process plants or process areas - Assembly of the pipe racks starts before the completion of the building - Transportability of all plant equipment - Higher quality standards despite shorter execution times - A maximum work safety, 0 error approach This presentation will illustrate concepts and engineering approaches for mastering these challenges and will be supported by examples from successfully completed projects using pictures, VR samples as well as first-hand experience reports from construction sites. Conclusion: - Prefabrication and flexibility do not contradict each other. - Super skids for pipe racks are possible and make sense. - Execution times are reduced when using prefabricated skids, while at the same time quality and work safety are increased.
  • 1145 - 1315
    Blockchain: The GAMP® Aspects
    Distributed Ledger Technologies (e.g., blockchain) have continued to gain momentum within the industry with several use cases being taken into production. This session is a continuation of the great discussions poised in the 2019 Annual Meeting where we will discuss additional use cases and lessons learned. In addition, this year we will begin to explore some of the supporting technologies and tools (e.g., IPFS, Zero Knowledge Proofs, etc) that are being leveraged to support blockchain use cases and the impact that these tools may have on our regulated environments. As a result of this session participants will gain a better understanding of the current state of blockchain within Life Sciences and be exposed to several of the foundational tools that make the application of this technology possible. This discussion will push the audience to contemplate the impact of these technologies in their current processes and help them prepare for the future.
    Session Leaders
    Speakers
    Presentation Information
    [Blockchain: Pharma Industry Update] This session, led by the CEO of Hashed Health, will cover the latest trends and advancements in blockchain and distributed ledger technologies specific to the pharmaceuticals industry. The presentation, followed by Q&A, will focus on the current landscape of solutions in production, the networks of companies collaborating to solve problems, and the design patterns emerging as focus areas for blockchain and DLT business models. || [Innovative Medicines Initiative (IMI) PharmaLedger Project] Sponsored by the Innovative Medicines Initiative (IMI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) under the Horizon 2020 programme, PharmaLedger is a 36-month project that brings together 12 global pharmaceutical companies and 17 public and private entities; including technical, legal, regulatory, academia, research organizations and patient representative organizations. The goal of the project is to provide a widely trusted platform that supports the design and adoption of blockchain-enabled healthcare solutions while accelerating delivery of innovation that benefits the entire ecosystem, from manufacturers to patients. Daniel will provide an overview of the project scope, relevant technologies and standards and selected use cases in development for Supply Chain, Clinical Trials and Health Data.
  • 1145 - 1315
    Phase Appropriate GMPs to Develop & Deliver ATMPs
    The recent massive growth of Advanced Therapeutics, in both the US and EU, continues in parallel with the steep learning curves of both the regulators and the industry on how to manufacture, regulate and provide effective and safe products to patients. The regulations are rapidly evolving to accommodate the variety of technologies, gene delivery modalities and target diseases. These regulations both facilitate and challenge the industry to adjust and refine how the implementation of phase appropriate cGMP's is a critical success factor for process and product development and delivery to patients. The session will address the key aspects to deliver an effective and efficient product characterization program, identifying the product Critical Quality Attributes from the earliest possible stage and the phased introduction of appropriate cGMP's that underpin a ‘Go Slow to Go Faster’ approach. Presentations will be based on two ongoing ATMP programs, one US, one EU. 1) Defining and implementing ‘phase-appropriate GMPs’ to balance quality, efficacy and speed in developing and delivering ATMPs; .2) The regulatory initiatives with respect to product development acceleration support are proactively supporting manufacturers; 3) In early stage programs, the success of practically applying QbD principles, from TPP to Control Strategy relies on organizational agility.
    Speakers

    Andy Stober

    Chief Manufacturing Officer
    Encloded Terapeutics, Inc.
  • 1145 - 1315
    Data Analytics
    Methods to harness data and models of pharmaceutical manufacturing processes from API to drug product is the focus of this session. Leveraging this information can enhance process understanding, improve process robustness, increase efficiency and manage risk. Topics include the proper use and interpretation of statistical methods, combining mechanistic models and traditional data-driven methods, and predictive analytics for equipment. Utilization of these tools can result in better process design and performance and assure quality across the product lifecycle.
    Session Leaders
    Speakers
    Presentation Information
    [Digital Design and Operation in the Pharmaceutical Industry] Based on scientific process understanding, mechanistic models offer a science- and risk-based approach to pharmaceutical process design and operation, in the original spirit of the QbD definition. However, mechanistic-model based digital twins offer a significant reduction in data requirements than traditional DoE-based approaches. In this talk, we will compare and contrast mechanistic model-based approaches to QbD with traditional DoE-based approaches. Industrial case studies will be presented that demonstrate digital design and operation of pharmaceutical manufacturing processes, including drug substance and drug product manufacturing. Virtual design space exploration will be illustrated as a tool for model-based risk assessment and identification of truly critical formulation and process parameters. The role of data-driven models will be presented, and model qualification and regulatory implications will be discussed. || [Implementing Real Time Predictive Manufacturing Analytics] Process industries generate enormous volumes of data but most have not optimized this valuable asset to generate operational intelligence. Rapidly advancing analytic models as well as increasingly cheaper computational and data storage costs allow a manufacturer to utilize operational data already being collected to increase productivity. Predictive Analytics uses real time data, machine learning models, and visualization platforms to compare current versus past performance of an equipment asset to forecast and alert on degrading asset conditions before they become a safety, quality, waste, or downtime event. In addition, Predictive Analytics can significantly lower maintenance costs as manufacturers avoid reactive or unneeded interval-based maintenance. This session will describe the steps to implement Predictive Analytics for process equipment assets with highlights on some of the key decisions required. || [Caution: Statistics Ahead! Common Mistakes to Avoid in Process Validations Statistics] The use of statistics across the product lifecycle has increased dramatically since the adoption of the 2011 FDA Guidance for Process Validation. This paradigm shift has certainly improved understanding of processes, increased robustness and managed risk. but with this increase comes the risk of inappropriate methods, unnecessary analysis, and incorrect interpretation. The consequences can vary from minor, such as a small waste of resources, to an increase in patient risk resulting from a flawed analysis. In this talk, several common mistakes that are made in typical application of statistical methods for process validation are shown by example. Three Key Points 1. Custom DOE designs and definitive screening designs can be incredibly efficient – but with that efficiency comes complexity and the danger of misinterpretation 2. If the concept of statistical uncertainty is not understood, inappropriate conclusions can be made regarding the need for sampling and process capability. 3. Significant CPV resources can be wasted if fundamental concepts for the use of SPC tools and capability metrics are not understood.
  • 1145 - 1315
    Annex 1: Manufacture of Sterile Products
    Eudralex Vol 4 Annex 1 draft has been released for comments ending May 2020. Share Industry comments supported by ISPE. as recognized organization for collecting comments. The session aims to introduce comments submitted to European Commission by ISPE, discussion on these topics. Regulators from around the world have been invited to discuss these comments or having regulators giving presentations on the draft and comments. Many regulators from the PIC/S drafting group will participate in this panel session.
    Session Leaders
    Speakers

    Jörg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
  • 1145 - 1315
    iLAB: Intelligent Lean Lab
    This session will address the following challenges faced by labs in pharmaceutical industry: tight profit margin, fluid demand for type of tests, globalized supply chain, and fragmented operational resources. Intuition indicates that if we bring all operational resources under one single digital platform, create a virtual image of the physical laboratory, we should be able to track and manage resources to optimal efficiency. Despite having the IoT technology around for some time now, we have been unable to create a lab that can be managed virtually. The reason is that reliance on technology alone makes the digitization process cumbersome and nonsensical. The above approach fails because the framework must first be organized using the principles of Operations & Supply Chain Management (OSCM) & Lean. Once the framework is successfully developed, automation and IoT technology should be used to digitize this framework. The presentation will propose an example of such a framework. Learn how to develop lean, flexible and process driven lab layout and how to use prevailing automation technologies to create a fully automated lab.
    Speakers
    Placeholder Person Graphic

    Komal Hatti

    Sr. Process Architect
    Integrated Project Services
  • 1400 - 1530
    Electronic Validation Implementation
    ElevateBio is creating and operating a portfolio of cell and gene therapy companies through partnerships with the world’s most innovative scientists and inventors. BaseCamp, in Waltham, MA, is their centralized R&D and manufacturing facility which is structured to rapidly and efficiently build single- and multi- product cell and gene therapy companies. The facility has fully-integrated capabilities, including basic and translational research, process development, cGMP manufacturing, clinical development, regulatory affairs, and commercial operations. The BaseCamp facility’s modernized approach to operations follows Pharma 4.0™ trends and is intended to utilize digitalized platforms like electronic batch records within the manufacturing suites. As part of this initiative, Kneat was implemented as a paperless validation software for the company’s commissioning, qualification, and validation (CQV) effort. Paperless validation software provides a way to streamline and optimize the CQV activities. The implementation of Kneat required cross-functional collaboration across departments to ensure that the software aligned with both the CQV risk-based approach and the company’s supporting Operations systems. The implementation of the software occurred in parallel with the creation of the company’s supporting systems including CQV, asset management, calibration, maintenance, etc. for facilities, utilities, equipment, analytical instruments, and computer systems.
    Session Leaders
    Speakers
  • 1400 - 1530
    Quality 4.0
    Digitalization has reached the Pharmaceutical Industry. The ability to leverage the potential of data to master processes and products as differentiator has been understood. The transformation from a classical documentation-based, functionally segregated towards a data-driven, end-to-end integrated production and quality management is one major objective towards the Pharma 4.0. The Holistic Control Strategy and Digital SOPs are enabler and accelerator for Pharma 4.0. The panel/roundtable session will start with 2 short presentations: 1. "ISPE Pharma 4.0 Holistic Control Strategy Model", Christian Wölbeling 2. “The SOP of Future – the right information at the right time”, Heike Röder about the principles of HCS and Digital SOP and how the world might look like under the assumption of full digital implementation. This presentation will include a short mock-up of integration of digital SOPs into a shop floor execution system, in this case manufacturing Execution System/MES. Followed by a discussion of the audience and/or participants of the panel/roundtable with regards to the following questions (and further questions coming from the audience): 1) What kind of initiatives do you run to improve/transform you product supply and/or SOP Management towards digitalization? 2) What are the benefits you are expecting? and 3) What are the risks?
    Session Leaders
    Speakers
    Presentation Information
    [The ISPE Pharma 4.0TM Operating Model - What is Pharma 4.0?] The ISPE Special Interest Group Pharma 4.0TM Operating Model was developed to apply the Industry 4.0 or also often called Smart Manufacturing principles in pharma and biotech manufacturing. This holistic end to end approach is covering supply chains from the starting material up to the patient or even also patient to patient. The mission of the group is to provide practical guidance, embedding regulatory best practices, to accelerate Pharma 4.0 transformations. The objective is to enable organizations involved in the product life-cycle to leverage the full potential of digitalization to provide faster innovations for the benefit of patients. The introduction of advanced automation and the increasing inter-connectivity of Industry 4.0 is not only revolutionizing the Pharma industry but also introducing many new challenges and production roadblocks. Shifting the paradigm to Pharma 4.0 and focusing on the issues specifically surrounding pharmaceutical priorities will lead to improvements in productivity, quality, and security of the supply chain. It is still to get rid of the paper on the shop floor and to create efficient and accurate decisions based on the integrity of the data, which is the basis for these decisions.
  • 1400 - 1530
    Connected Medical Device Systems
    There has been a dramatic increase in the use of connected systems in our daily lives. This trend is starting to make its way into the medical device realm as users are able to collect more and more data about themselves through devices like Apple Watch and Fitbit. This presentation will provide information into the approaches and strategies that Lilly used while creating an Open Loop medical device system consisting of a mobile application, connected insulin pen, and a cloud that provides the backend to store all of the information that is generated. In the creation of this innovative system, Lilly needed to learn and implement best practices around medical device development, regulatory interactions, cybersecurity, and accounting for real world use of these devices. As a result of this session/presentation, participants will learn about what Lilly did to design, develop, verify, and validate the mobile app and connected insulin pen; the cybersecurity activities for the overall system; and challenges the team had to overcome while trying to achieve digital speed in traditional Pharma, including quality and regulatory hurdles.
  • 1400 - 1530
    Roads for CAR-T: Strategies for Cell Based ATMPs
    With a small number of approved cell therapies/ ex-vivo gene therapies and with those approved therapies reaching small patient populations there is not a proven strategy for successful large-scale commercial manufacturing. This session will briefly introduce different strategies for commercial manufacturing (e.g. centralized, regionalized, point of care, outsourced). Then move into a panel discussion to hear how various companies are pursuing commercialization and gain insights into the opportunities of these strategies. As a result of this session participants will hear from industry leaders about the regulatory, supply chain, and process technology enabling different visions of future CAR-T manufacturing.
    Session Leaders
    Speakers
    Presentation Information
    [Autologous Cell Therapy Manufcaturing - How do we scale out?] Autologous cell therapies, especially immunotherapies, are increasingly being developed and approved. However, there remain substantial manufacturing challenges. Solutions for more efficient manufacturing, scaling out, reducing COGS, and improving the processes and the product quality are crucial. We will discuss several novel approaches to addressing these challenges. || [GMP Manufacturing Scaleout for ATMPs] Cell and Gene therapy manufacturing offers the greatest challenges in terms of scalability and compliance. Since the first therapies have jumped into commercial, the major challenge remains the manufacturing of these therapies which is directly connected to CoGs (and therefore prices) and compliancy. In light of this wide challenge a real case study is presented along with some backgrounds infomation to show a brand new concept of cell factory already approved by authorities which along with GMP compliancy dramatically improves space occupancy and operations costs. Therefore in the session the participants will understand the rationale behind the selection of the manufacturing technology, learn the key inputs to approach suppliers in this field as well as get an insight for similar applications within the ATMP field.
  • 1400 - 1530
    Process Validation in Biotech
    ISPE’s Process Validation Team is a diverse and active group of SMEs from industry. This session will discuss emerging areas of focus for Process Validation of biotechnology products of interest to this group and industry at the present time. The topics covered will focus on how PV can be conducted under or support projects where development/transfer timelines are compressed or present specific challenges with emerging/new biotech entities.
    Session Leaders
    Speakers
  • 1400 - 1530
    Container Closure for Gene Therapy Products
    The presentation addresses the challenges associated with the small batch size required for gene therapy (and similar) products with specifics on considerations for solutions in overcoming those challenges related to filling and the container closure system. The presentation will include the challenges and how those challenges can be addressed through the use of glass vials and press fit caps. The testing methodology for container closure integrity testing of press fit caps (in place of traditional aluminum overseals) and manufacturing considerations required to ensure proper CCI will be addressed. The pros and cons of conversion to this style of closure versus traditional closures will be addressed. The important take-aways for this will be an understanding of how press fit caps address challenges for container closure of gene therapy products and how to assess a manufacturing system to determine if press fit caps are the right solution.
    Session Leaders
    Speakers
Day 5
Friday, 6 November 2020
  • 0900 - 1030
    Technology for Broad Spectrum Compliance & Function
    We are now in the 4th generation of biotech industry design practices and have seen the evolution of our philosophies succeed, fail and adapt. Over the past 40 years we have replicated antibiotic facilities, advanced to compliant cell culture and re-engineered our industry to adapt to cell and gene therapies. The objective of this session is to show a wide spectrum of the biotech facilities, the design philosophy and implementation. These facilities reflect today’s therapies ranging from bacterial phage, extracellular proteins and high potency systems. These presentations show the complexity of dealing with not only the FDA / EU biopharma regulations but those need to be balanced with OSHA, NIOSH, CDC, NIH, in the design and construction. This session will provide a good background for those looking at new facilities to be designed, and would like guidance into best practices and implementing compliance in a complex production.
    Session Leaders
    Speakers
    Presentation Information
    [Designing Facility for Biopharmaceutical HPAPIs] Cross-contamination risks could be fatal especially when it comes to HPAPIs. The target is to design a facility for biopharmaceutical HPAPIs that complies with US & EU GMP and EHS requirements and saves in CapEx & OpEx. US FDA provides high level requirements, while EMA provides more details in Chapters 3 & 5 and in its health based exposure limit guidance. Many publications such as ISPE guidance describe how to practically comply with GMP and EHS regulations in a cost effective manner. User requirement specifications are the starting point to design process and quality risk management plays a great role. Important inputs include cell lines bio-safety levels (BSLs) and products’ toxicological data with estimated OEL & PDE (ADE). Process understanding and process closure analysis are essential. Risk assessment for GMP and EHS risks is crucial to define required controls and containment strategy. Facility design should incorporate these controls in a practical and cost effective manner. Controls cover equipment design, layout and flow of personnel and materials, waste flow and waste treatment, clean room and HVAC. Finally, quantitative risk assessment is essential to evaluate effectiveness of these controls. || [Engineering & Construction of a BL-2 Plant for Bacterial Phage] The recent development of the CRISPR Cas3 technology has provided a new mechanism to implement synthetic biology to create a revolutionary alternative to traditional antibiotic therapy. By implementing gene editing we now have the ability to create bacterial phages to target and destroy antibiotic resistant bacterial infections in humans. The facility for production of this therapy requires the fusion of modern biotech design concepts, BL-1 and BL-2 safety, and several unique technology adaptations. The production of the bacterial phage requires the manufacture of virulent bacteria, downstream purification and fill finish. Due to the nature of the product and the relative size of each batch a 12,000 ft^2 facility was designed, engineered with several innovations and constructed to be completely self-supporting with production, development, utilities, and offices. The session will cover the process development, manufacturing, and production design and construction. As a result of the session the participant will learn about a new biotechnology process, the adaption to single use technologies, minimization of plant footprint, elimination of most utilities and the unique design and construction features to enable a safe production and compliance to FDA / EU / CDC / NIH. || [A Framework for Ensuring Business Performance for Multi-Product Facilities] This presentation will discuss the challenges with developing multiple product development programs while designing a facility to support multiple overlapping product programs. This presentation will be based upon Pharmatech’s experience in designing and deploying biologic, cell and gene therapy and High Potency facilities in the US and Asia.
  • 0900 - 1030
    Truth and Lies-Innovative Technologies & Pharma 4.0
    The next phase in the evolution of innovative data and process technologies has been available to the life science industry for quite a while. However, the industry has many false notions of the use, data integrity and vendors of these advanced technologies required to transform their manufacturing, learning, data analysis and quality systems. These three speakers will lead participants on a trek through Machine Learning (ML) as an increasingly used form of Artificial Intelligence (AI); to Pharma 4.0 Artificial Intelligence (AI) algorithms and finally SaaS Cloud Services. The speakers will steer participants across the treacherous pitfalls, on this innovative technology journey, concerning compliance, data integrity, inherent risks, health authority regulations/guidance and GAMP guidance.
    Session Leaders

    HOLLY BALDWIN

    Manager Quality Validation- Computer System Validation
    Sanofi Pasteur
    Speakers

    HOLLY BALDWIN

    Manager Quality Validation- Computer System Validation
    Sanofi Pasteur
    Presentation Information
    [UP: Rising to the Cloud Challenge] Having a background in life science and a SaaS LMS used in that industry; most life science companies do not understand how to implement cloud systems (SaaS), especially how they differ from traditional IT model and the vendor assessments as to 2017 2017 Q&A addendum to 21 CFR Part 11 (Clinical Investigations). Content: Traditional IT model vs Cloud IT Model, conducting an effective vendor assessment of cloud service providers (SaaS, IaaS or PaaS) Able to understand the different roles and responsibilities between the life science company and cloud service provider. Able to conduct an effective vendor assessment/audit of cloud service provider Able to revise internal SOPs to include usage and assessment of cloud service providers while still maintaining a validated quality system process || [Qualifying AI Algorithms: Gain a Complete Understanding of Your Processes with AI] As pharma and biotech look to implement Pharma 4.0 technologies to improve their manufacturing operations, there is trepidation about whether artificial intelligence (AI) algorithms are acceptable for use by regulatory agencies. A few years ago, the European Pharmacopeia promoted two AI algorithms (neural networks and support vector machines) as valid chemometric methods yet little has been done to make a difference. AI has been considered as software with abilities to learn by the FDA and its usage requires specific governance. AI cannot be validated as a classical statistical method or as a conventional software classified as GAMP 3, GAMP 4, or GAMP 5. During this presentation, the ingredients required to get AI insights will be introduced and a proposal to qualify AI algorithms as well. This proposal has an immense amount of research behind it and provides a standard methodology to qualify AI algorithms using the Design of Experiments (DoE) methodology and shows how they are safe to use. Data, algorithms, models, and scores are the principal elements to create AI. The qualification of AI algorithms is part of the required chain that must be applied for each ingredient involved in AI application for GxP frameworks. Additionally to the AI algorithm qualification based on DoE, an innovative perspective regarding the AI life cycle will be provided. || [Data Integrity for Machine Learning] As an innovative technology in the pharma world today, Machine Learning (ML) is an increasingly used form of Artificial Intelligence (AI). However, the key difference in ML is the volume of data which is required in order for such technology to be successful. In requiring such, the integrity of this data (i.e. Data Integrity) is of paramount importance. This presentation shall reinforce the elements of data integrity (DI) already presented in current ISPE good practice guides and explore the uniqueness and importance of this concept in ML. Attendees will learn key reasons for proper data governance in ML, and be able to identify the inherent "pitfalls" in selecting, preparing and utilizing data for ML.
  • 0900 - 1030
    Digital Transformation and Smart Manufacturing
    Manufacturers are leveraging a wide array of technologies and approaches for smart manufacturing. They believe technologies, processes, people and workplaces are critical to the digital transformation, IIoT and Industrie 4.0. Companies are striving to increase production while improving quality and complying with regulatory requirements. And more recently remote operations have been brought to the forefront. What are some of the leaders doing, what challenges are they overcoming, what challenges and workplace modifications are critical and what are they doing to leverage them right now. Join this smart manufacturing session to find out what manufacturers are actually doing in the pharmaceutical, biotech and other industries to improve manufacturing and learn about some of the next gen technologies and approaches that really work.
    Session Leaders
    Speakers

    John B. Noble, PhD

    Vice President & General Manager, Life Sciences
    Jacobs Engineering Group Inc
    Presentation Information
    [Digital Transformation in Manufacturing] Manufacturers are leveraging a wide array of technologies and approaches for smart manufacturing. They believe technologies, processes, people and workplaces are critical to the digital transformation, IIoT and Industry 4.0. Companies are striving to increase production while improving quality and complying with regulatory requirements. And more recently remote operations have been brought to the forefront. What are some of the leaders doing, what challenges are they overcoming, what challenges and workplace modifications are critical and what are they doing to leverage them right now. Join this smart manufacturing session to find out what manufacturers are actually doing in the pharmaceutical, biotech and other industries to improve manufacturing and learn about some of the next gen technologies and approaches that really work. Key Takeaways: 1. Digital Transformation in Pharmaceutical - How Industry is Adopting 2. What really works and what other manufacturers are doing 3. The benefits and value of digital transformation || [A View into Pharma 4.0 Technologies to Support Human Activity] Pharma 4.0 is on everybody's mind at the moment yet the benefits are often not understood. Digital initiatives are now commonplace, with some signs of results. But the reality is that pharmaceutical manufacturers are still trying to understand the practicalities and benefits. How can we improve bottom lines, increase quality, mitigate risk of noncompliance, and increase efficiencies with these technologies? We know that gains don’t come from technologies by themselves, so what does this look like in practice? In this talk, I’ll shift the focus from technologies themselves to the people who use them. The Pharma 4.0 initiative clearly shows the relationship between technology, process and people. People are the key to unlocking productivity gains from digital technologies, that therefore have to focus on supporting human activity. They don’t necessarily mean lengthy and complex implementations and they are most successful when they happen bottom-up. Paper and spreadsheets are still the norm in pharmaceutical manufacturing and a lot can be gained by simply digitizing manual processes. The presentation will exemplify how a complex setup process was digitally transformed using visual and interactive work instructions resulting in superior visibility into the process and increasing operator efficiency through involvement and empowerment. || [Building a Workforce to Fuel the Future of Pharma] With Pharma 4.0 comes increasing focus on speed-to-market, adaptability and cost of goods, all requiring manufacturing solutions that were unthinkable ten years ago. We have reached the limits of working faster and longer; now we must work smarter. Fuelling innovation and harnessing the full potential of Pharma 4.0 depends on our ability to successfully integrate an inclusive, innovative and sustainable workforce with the latest digital solutions. John Noble will discuss how Pharma 4.0 demands a new approach to foster more innovative, agile and inclusive ways of working. He will present a holistic strategy drawing on case study examples and providing delegates with tangible actions in three core areas: - People – re-imagining the talent pipeline and creating an inclusive and collaborative culture for connected decision-making - Technology – integrating talent with emerging technologies - Workplace – creating the physical spaces to strengthen collaborative, integrated problem-solving Key Take-Aways: 1. Innovation in pharma manufacturing is contingent on integrating an inclusive, innovative workforce with new technologies. 2. Creating the future workforce requires a three-pronged approach focused on People, Technology & Workplace 3. Theory in action: Maximizing inclusion and collaboration strengthens innovation and efficiency (case study)
  • 0900 - 1030
    Flexible and Modular Manufacturing
    The customer and market requirements for the aseptic filling of medicines are steadily increasing. There is a clear trend to smaller batches for different types of ready-to-use containers (vials, syringes, cartridges) and high value drugs. At the same time approximately 25% of all NCEs are classified as high-potency with OELs (occupational exposure limits) below 10ug/m3 with this number expected to grow. This leads to a growing need for flexibility within the life science industry and therefore the need for development of new flexible and modular equipment as well as modular facilities. In this session the different presentations will cover the development of a new flexible production cell, the development of a flexible state-of-the-art facility for high-potency manufacturing and finally how modular facilities can accelerate product development while reducing development costs.
    Session Leaders

    Jörg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers

    Jörg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Presentation Information
    [Flexible, High-Potency Clinical Manufacturing] Approximately 25% of all NCEs are classified as high-potency with OELs (occupational exposure limits) below 10ug/m3 with this number expected to grow1. Typically, pharmaceutical companies will either outsource high-potency products (40% of all outsourced products are classified as high-potency) or create dedicated facilities2. Merck’s innovative strategy is to build a new, state-of-the-art facility with flexible, high-potency manufacturing to include both modular and podular design features. Specifically, the oral solid dosage high-potency suite is being built with modular walls that can be moved or rearranged depending on program and facility needs. Additionally, all the equipment intended to be used within the facility will be movable or portable including the high-potency equipment. This flexibility will enable many different types of process trains at varying scales to be run within the high-potency suite without needing space for dedicated equipment. These process trains include blending, roller compaction, compression, encapsulation, and film coating up to 75kg for compounds with OEL down to 1µg/m3. For compounds with OEL < 1 µg/m3, flexible isolation technology will be used for manual encapsulation processes of up to 10kg. || [Modular Engineering in the Life Sciences Industry] a. The life sciences industry, particularly cell and gene therapy production, grapples daily with the need to accelerate product development while reducing development costs. Modular facilities are on the rise as life sciences manufacturers seek to achieve the manufacturing agility needed to respond to market conditions through reduced facility footprint, standardized processes and improvements in design-to-production timelines. How are control solutions evolving to support modular facilities and in turn, modular engineering in batch manufacturing? Speed and flexibility requirements are now more critical than ever. b. The combined flexibility achieved from decoupling of IO from controllers, decoupling of software from hardware, balancing automation resource usage, and consolidating and hosting workloads in a data center allows easier equipment configuration, control strategy changes, and software updates. c. Learn how, along with increased visualization of production timelines, modular engineering techniques - lower project delivery and lifecycle costs, - better leverage employee skills, and - drive consistent physical and cyber security management. || [Creating a New Industry Standard for Fill/finish of Small Batches] The customer and market requirements for the aseptic filling of medicines are steadily increasing. There is a clear trend to smaller batches for different types of ready-to-use containers (vials, syringes, cartridges) and high value drugs. For a contract manufacturer this means a higher number of changes from one batch to another and the absolute need for high yield. For very small batches (up to 3.000 to 5.000 containers) Vetter has been looking for a small, fully automated, flexible production cell. The use of robotics and a reliable process with “no-glove-intervention” are key requirements. These requirements are based on the cumulative experience with a wide variety of drug substance types (monoclonal antibodies, fusion proteins, peptides, oligonucleotides and others) and container systems. New container systems could also bring challenges in handling and dimensions that cannot be processed on existing machines, for example specially designed cartridges for on-body-delivery systems (aka wearable devices). Adaptability and flexibility are therefore paramount. For developing such a production cell according to their needs Vetter has chosen Syntegon Technology as a partner. Syntegon Technology brings to the project the technical experience on the machine side and the willingness to think outside the box.
  • 0900 - 1030
    Combination Products Part 2: Evolving Regulations
    US FDA has continued to evolve the regulatory space for combination products in the United States, EU MDR implementation is upcoming. Efforts to align definitions are underway through ASTM International. In this session we will get health authorities perspectives on the dynamic combination products regulatory space, what's working, what's challenging, what's next.
    Session Leaders
    Speakers
    Placeholder Person Graphic

    Lynn Lundy

    Sr. Director, Regulatory Affairs
    West Pharmaceutical Services
    Presentation Information
    [ EU MDR: Impact on Combination Products] This session will cover European combination product regulatory perspective based on the introduction of the Medical Device Regulation (MDR). It will cover co=packed devices, combination product rules and Article 117 requirements.
  • 0900 - 1030
    Make vs Buy Business Analysis in Advanced Therapies
    In a moderated panel discussion, Project Farma details the considerations used in determining whether an advanced therapy company should manufacture therapies internally or utilize external third-party manufacturers. This discussion explores the rationale of gene and cell therapy companies using an external CMO or relying on internal manufacturing. With insight from one advanced therapy company that utilizes third party manufacturing, and another that manufactures internally, Project Farma provides the considerations for both cases along with perspective from a CMO regarding external manufacturing.
    Session Leaders

    Tony Khoury

    Vice President, Technical Services
    Project Farma
    Speakers
  • 1130 - 1300
    A Historic Legacy Facility Strengthening Its Future
    In the ever-evolving environment of parenteral product manufacturing, legacy facilities are struggling to meet current expectations for cost reduction, flexibility and regulatory compliance. These once state-of-the-art facilities are looking for a practical approach to modernization, to continue manufacturing high quality products while they plan for the future. Par Pharmaceuticals has done just that through its investment in their Rochester Facility, a site that has an important role in the history of the pharmaceutical industry. The Suite C expansion project resulted from master plan efforts that considered multiple important facets of the upgrade, including technology, facility compliance and workforce development. Bryan Kistner will discuss the owner side challenges of producing products in today’s parenteral environment. He will also discuss what it is like to navigate the internal complexities of bringing such a project from initial conception to successful completion. Paul Valerio will discuss the latest technology being used in Suite C with the adoption of isolators, automated material handling, and the nuances of multi-product concurrent manufacturing. Jason Collins will discuss the importance of master planning and establishing a future vision along with the details of facility design aimed at flexibility and regulatory excellence.
    Session Leaders
    Speakers

    Paul F. Valerio

    Director, Process Technology / Associate
    IPS - Integrated Project Services, LLC
    Placeholder Person Graphic

    Bryan Kistner

    Senior Director - Eng Program Mgmt
    Par Pharmaceuticals Inc
  • 1130 - 1300
    Digital Transformation to Pharma 4.0
    Out of the wide area of Pharma 4.0, this session will focus on the perspectives inferred from experiences. From the lessons learned in practical cases to visible scenarios, in Pharma 4.0 unfolding reality and potential. Experiences from design and deployment of a Pharma 4.0 company-wide roadmap, from Zero Trust Architecture as a security model for a 4.0 authentication, from deployment of the Digital Twin concept for a 4.0 Engineering.
    Session Leaders
    Speakers
    Presentation Information
    [Digital Twin: The Last Frontier of Pharma Production] Digitization will substantially influence the drug manufacturing process in future. This is reflecting also on the engineering activities, allowing new design processes and a deeper knowledge of production plants. The presentation will show the innovation process in digitization done by an Engineering company, in order to support life sciences companies to make their next step into the future. Focus will be on the process to select the appropriate tool, the project road map, the different activities planned and executed, the lessons learned, the difficulties encountered and finally the results gathered. We will discuss how to define digital readiness and move it one step ahead, in order to get ready for a project execution based on a digital twin. A multi discipline team is called to find the appropriate design tool for engineering activities, with the target to design the entire project with one single application and enable the delivery of an integrated process and facility digital twin. The advantage of the digital twin will be reflected into the possibility to - use virtual reality for project review, - use augmented reality for maintenance purposes, - fasten plant modifications, recognizing early any possible issue with the 3D design. || [Pharma 4.0: Scenarios, Lessons Learned, Directions] a. Title: “Pharma 4.0: scenarios, lessons learned, directions” Where we are and what’s next: a map from practical cases b. Main agenda: • Industry 4.0 and Pharma 4.0: what is it, where is the value • Pharma 4.0 directions: an example by the Italian “manifesto” for the next decade • Pharma 4.0: where are we? Few comments on the ISPE Pharma 4.0 SIG global survey • Pharma 4.0: what to do. A mountain to climb, lessons from practical projects on: . Conceiving the roadmap . Using the roadmap . Using (or rather not using) the roadmap: lessons learned c. Final takeaways: 1. where is the value 2. compare your Pharma 4.0 maturity with your peers 3. Pharma 4.0 it's a mountain to be climbed: many of us are at the beginning at the ascent. I will share my experience on the field in delivering 4.0 Strategy and Roadmaps describing practical case studies. Without a sound Pharma 4.0 roadmap we will struggle in reaching our goal: the Pharma 4.0 peak. I will share that the peaks could be different for everyone of us and that there may be more than one path to reach it. || [Zero Trust Architecture as Part of a Pharma 4.0 Strategy] Zero Trust Architectures assumes all assets inside or outside the network must be authenticated. Deploying Zero Trust across a factory LAN or across a supply chain coupled with data encryption greatly enhances the the integrity component fo the data acquisition process. For supply chains which stretch outside the US, Zero Trust is compatible with the fundamental requirements of GDPR and other privacy regulations., This presentation will discuss the basic considerations when considering a zero trust framework and how it can be deployed as part of a Pharma 4.0 strategy.
  • 1130 - 1300
    Development & Manufacturing Challenges with ATMPs
    Cell and gene therapies represent a significant opportunity for novel therapies which address unmet medical needs, but pose some new challenges for process development and commercial manufacturing. Hear from three industry leaders on how they and their firms have addressed these challenges to bring these life-saving products through development.
    Session Leaders
    Speakers
    Placeholder Person Graphic

    Li Chen

    Process Engineer II
    BlueBird Bio
    Presentation Information
    [Process Validation of Suspension Lentiviral Vector Process] A seamless and efficient process validation at the launch manufacturing facility is necessary to ensure a successful regulatory filling and product approval for a scalable single cell suspension process for lentiviral vector production to be used in advanced therapy medicinal products (ATMPs). A case study of a lentiviral vector process validation at a new contract manufacturing facility will be presented. Topics of discussion will include Initial technology transfer challenges, process equipment capability assessments, alignment of process validation policies, challenges in establishing a process control strategy, real-time support for manufacturing deviations during the process validation campaign, pre-approval inspection preparations, and the complexities faced in creating efficient workflows between internal and external cross functional teams. Lessons learned from this case study will also be discussed to improve the efficiency of future process validations. || [Rapid vaccine/viral vector deployment using flexible biomanufacturing platforms ] With the rise of viral vectors for gene therapy applications, and the current pandemic due to COVID-19, single use manufacturing facilities have never been so relevant. Speed and flexibility are the essence for these difference therapeutic modalities. We will share some of the current trends & challenges we are seeing, as well as sharing a case study about scaling up a viral process through full scale manufacturing. || [Cell Therapies - New and Old Challenges] Cell therapies represent a significant opportunity for novel therapies which address unmet medical needs, but pose some new challenges for process development and commercial manufacturing, and rekindle some old challenges from the development of recombinant DNA-derived purified protein products. These include establishment of new supply and distribution chains, novel technical issues, raw material quality concerns, product quality concerns, and product safety concerns. The use of accelerated approval regulatory schemes such as breakthrough designation add further issues for CMC strategy which must be successfully addressed prior to product approval. Examples of these issues and strategies will be discussed.
  • 1130 - 1300
    Performance-Based and Advanced Control Strategies
    Performance-based control strategies as defined in ICH Q12 and advanced control strategies based on PAT, soft sensors, and other mathematical approaches for controlling and optimizing a pharmaceutical manufacturing process in real-time, is one of the latest opportunities for smart and efficient manufacturing. However, the applications of these control strategies are still in the early days and how to develop, implement, validate and maintain these are a topic that is still not fully understood and is an ongoing discussed between the industry and regulators. The session we will provide examples of these performance-based control strategies applied for continuous OSD manufacturing and biologic processes and we will discuss advantages, opportunities and challenges in the perspective of life cycle management.
    Session Leaders
    Speakers
    Presentation Information
    [Advanced Control Strategies and Applications for Continuous Drug Product Manufacture] The new continuous direct compression (CDC) line at AZ Gothenburg is equipped with multiple PAT and monitoring tools enabling high flexibility for control strategy approaches. It will be demonstrated that different options are viable to ensure drug product quality compliance as described by ICH Q10. However, more advanced control strategies could further improve quality and moreover improve process performance significantly. Given that 61% of drug shortages are caused by quality issues (FDA), advanced control strategies could be a game changer in pharmaceutical manufacturing. Therefore, we developed an upgrade project for our CDC line enabling advanced monitoring and control. Firstly, IT and automation infrastructure requirements were identified as full digitalization of the line is critical to the success of the project. Secondly, several digital platforms were selected to achieve the targeted benefits. Lastly, the complementary between the selected platforms will be discussed.
  • 1130 - 1300
    Supply Security in Cell & Gene Therapy Manufacturing
    Supply chain complexity in advanced therapies is driven by the three "Ps" of Patient, Process, and Product, with highly variable starting materials (patients), highly complex manufacturing (process) and highly regulated therapies and medicines (product). This session will bring a variety of perspectives from well-known presenters in the field, covering the challenges of establishing, managing, and executing a highly dynamic supply chain in a rapidly evolving industry. The panelists have significant experience in CMC , patient material collection and qualification, and clinical material manufacturing, from biopharma, clinical center manufacturing, and the tissue and blood banking industry. Key takeaways will include anticipating and scaling manufacturing supply chains for cell and gene therapies, the pitfalls of advanced therapy manufacturing, and strategies to assure success at all phases of clinical development through commercial manufacturing.
    Speakers
    Presentation Information
    [The Impact of Cell/gene Therapy Construction on the Supply Chain] While the Cell and Gene Therapy industry explodes across the globe, the critical supply chain that supports the growing industry is having trouble keeping up. Each member of the supply chain who plays a role in bringing these facilities online, including designers, trade partners, equipment suppliers, general contractors and bulk media suppliers, to name a few, are seeing major impacts which in turn is impacting schedule, cost and quality of these facilities. In some cases, the impact is so large that it prevents companies from moving forward at all. This session will use data and examples from more than ten projects, each in different stages of design and construction, to showcase potential solutions for avoiding and/or mitigating the supply chain impact. By implementing these lessons learned, companies can start taking steps today to lessen the impacts. As a result of this session, participants will: 1. Understand the gravity of this issue and the potential impacts that are either delaying the speed to market or halting this life changing therapy. 2. Learn about the steps that can be taken to avoid or mitigate these issues and continue to bring their facilities online on-time, on-budget and without sacrificing the necessary quality.