Agenda

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Technical PresentationLive-streamed education sessions.

Before the Event
Monday, 27 June 2022
Day 1
Tuesday, 28 June 2022
  • 0700 - 1700
    Registration Open
  • 0730 - 0845
    Continental Breakfast
  • 0845 - 0900
    Welcome and Opening Remarks
    Speakers
  • 0900 - 1030
    Opening Keynote Session
    As the global biopharmaceutical industry continues to grow and evolve, companies, regulators and scientist are constantly facing pressures to focus on the patient as they improve the quality, efficacy, safety, cost, and compliance of their life-saving products.  The Biotechnology Conference brings together the “who’s who” of biopharmaceutical executives, regulatory directors that operate in the space, cutting-edge technology providers and scientist.  The audience will hear from premier speakers to indulge their thirsty minds.
    Session Leaders
    Speakers
    Presentation Information
    [Advancing the Manufacturing of Complex Biologic Products]
    Speaker: Peter Marks, MD, PhD
    Manufacturing is a critical aspect of complex biologic products. The adage that “the process is the product” is all too true. This has only been highlighted by the COVID-19 pandemic during which limitations in manufacturing were encountered and have had to be overcome. Advancing manufacturing technology is critical for the production of complex biologic products on a small, medium, and large scale. Right now there a Goldilocks phenomenon present: manufacturing appears to be best suited to the medium scale. However it will be important that we can both scale down and scale up in order to meet important medical needs. FDA is conducting and sponsoring applied scientific research and refining the regulatory framework for advanced manufacturing. The agency will also be working with academic, industrial, and federal partners to help advance the field.
    || [Manufacturing of High Precision mRNA Medicines Against Cancer]
    Speaker: Oliver Hennig, PhD
    mRNA technology has opened the door to a new world of medicines. The platform technology is adaptable and allows for a fast, scalable, and thus flexible manufacturing. These properties specifically make this novel drug class not only ideal to tackle a pandemic but is well suited for the application for high precision medicines. Individualized mRNA-based cancer immunotherapies are one approach to address the individual genetic mark up of tumors and have the potential to close a gap in cancer treatment. While the technology is one important pillar, manufacturing is key to translate the technology and drug design into the final drug product. BioNTech has developed an on-demand manufacturing process to design and manufacture individualized mRNA-based cancer vaccines based on its iNeST platform in clinically relevant timeframes, also by employing next-generation sequencing and AI-based bioinformatic neoantigen discovery. Today, this expertise and know-how has been incorporated into a modular and turnkey manufacturing solution based on a container that can be easily shipped and built up to support a decentralized and scalable mRNA vaccine production that addresses local needs.
    || [Biopharmaceutical Manufacturing Innovations on the Horizon]
    Speaker: Narendra Bam, PhD
    Innovations in biopharmaceutical manufacturing will be highlighted with examples from GSK’s manufacturing technology development portfolio of projects. This will include continuous manufacturing of mAbs and a new continuous manufacturing platform for sterile product manufacture. Recent reflections of supply chain disruptions and solutions implemented due to COVID-19 will also be described.
  • 1030 - 1115
    Break in Expo Hall
  • 1115 - 1300
    Concurrent Session: Operations Readiness, Tech Transfer & Risk-based Case Studies
    The Biomanufacturing Industry has risen to a number of challenges in supply chain, drug shortages, and global deployment of manufacturing capabilities in connection with the new geopolitical map and current market needs. We have successfully introduced new ways of working and collaborating between industry and regulatory agencies starting with development and clinical trials and ending at the patient’s side. This session will provide examples of ways of working that have proven beneficial for these processes and highlight how we can continue to develop our ways of working and communication channels to further improve the global reach of our products to meet the patient’s needs. Operational readiness and a focus on reducing environmental impact as well as other areas of sustainability are important factors to further this area of production in a responsible way. The work we do now gives us an excellent opportunity to keep those aspects in everything from design for new as well as retrofitted facilities, drug formulation, and logistics solutions.
    Session Leaders
    Speakers

    Josef Herzog

    Associate Director Automation
    Zeta Automation GmbH
    Presentation Information
    [Automation for the Integration of Single-Use Equipment]
    Speaker: Josef Herzog
    Single-use (SU) technologies have been increasingly incorporated into the manufacture of biopharmaceutical products over recent years. While the reasons for implementing such systems are compelling, there are still some concerns related to their use. Process automation is one such concern and is often considered a weak point of SU technology. Automation islands are frequent phenomena and integrating the equipment in larger automation environments remains challenging.

    There are extensive ranges of SU equipment on the market, including an array of bioreactors, for example, with different configuration options. As far as software is concerned, in most cases, one single solution is offered, which is based on the supplier's own standard. The situation is similar with measurement technology: each supplier relies on its own special standard thus reducing flexibility. There is usually a need for a single, specific standard that applies to the operation of the entire plant and allows the integration of new equipment at any time without issue. In the case of existing facilities, it is important to be able to maintain the established, prevailing standard. This means that solutions adapted to specific requirements are called for when it comes to the integration of SU, metrology and sensor technology.
    || [Retrofit and Debottleneck your Facility]
    Speaker: Ronald Berk
    Companies have used CMO’s to supplement the production or have build new facilities to meet market demands. But covid has resulted in backlogs and capacity shortage at CMO’s, in particular in fill finish. The supply chain issues and inflation, raising the cost and stretching delivery dates, make building of new facilities less attractive as well. This makes that retrofitting and debottleneck existing facilities have become an attractive alternative.

    Retrofitting for new products with higher titers impact the purification operations and the buffer system supporting this purification. Bottlenecks created by solution prep, purified water systems and CIP systems are common challenges in retrofitting and debottlenecking. These challenges can be addressed with technological developments. For example, closed processing, single use technology, in-line dilution or buffer formulation and others are great tools in a retrofitting and debottlenecking toolbox.

    This presentation will discuss common challenges and solutions used in case studies that have supported retrofitting and debottlenecking of existing facilities.
    || [Biologics Facilities: from now and to the future]
    Speaker: Carl Carlson
    Biologic Therapies cover a wide range of manufacturing platforms and complexity of manufacture. The resulting action of the biologic can dramatically improve medical conditions for a wide range of ailments (cancer, genetic disorders, viral infections, microbiome Therapies and treatments). These products can be manufactured in a large range of Pharmaceutical facility requirements. The Manufacturing process complexity begins with the research and development scale of the operation and then progresses to the manufacturing scale facility. Once a molecule is identified and has proven potential/efficacy, the process of production, extraction or product molecular modifications are defined for the scale of production. Looking at some of the more prevalent Biologic Therapies and their Compound Annual Growth Rates (CAGR), one can speculate where the future investments and facility demands will be focused. Some of the more prevalent therapeutics are: Monoclonal Antibodies (mAbs), Vaccines, Plasma Fractionation, Advanced Therapy Medicinal Products (ATMP), Microbiome Therapeutics, and Oligonucleotide Therapeutics. The future trends are best focused on standardizing the process steps and thereby streamlining product delivery. A standardized class of unit operations can then be focused on the optimal process and ideally would provide a standardized starting point for development labs in general.
  • 1115 - 1300
    Concurrent Session: Applications of mRNA Technologies
    The outbreak of COVID-19 brought the mRNA technology to light. From a silent long-term technology that needed to prove its potential, well behind other technologies like C&G therapies, to the focus of everyone's attention. Lead by Moderna, BioNTech and CureVac the number of players in this field is growing rapidly. New starts-up as well as establish pharmaceutical companies are now turning to mRNA. What are the exciting applications for mRNA technology beyond the COVID-19 vaccine? The goal of this session is to explore the potential of mRNA applications from vaccines to personalized medicines and beyond as a catalysator for such transformation.
    Session Leaders
    Speakers

    Jasna Curak

    Global Quality and External Collaboration Manager At Roche
    F. Hoffmann La Roche Ltd

    Aaron Allen

    Director, Manufacturing Sciences and Technology
    Moderna Therapeutics
    Presentation Information
    [ATMPs - GMP Challenges ]
    Speaker: Jasna Curak
    Advanced Therapy Medicinal Products (ATMPs) are already marketed in international markets and in many cases lack specific regulation. As a consequence, existing requirements used for traditional biological products may be applied without acknowledging the specific considerations for these new therapies. This presentation will focus on ATMP specific characteristics, where compliance to existing GMP frameworks may prove challenging, and review current ATMP specific GMP guidances.
    || [Spikevax™ Platform Introduction and Qualification]
    Speaker: Aaron Allen
    The rapid introduction of a pandemic vaccine created a challenge to the classical sequential approach to process characterization, transfer, and validation at production scale. The following presentation discusses a risk based and parallel characterization approach to process validation during the scale up and qualification of the Spikevax vaccine. Prior experience with clinical vaccine programs enabled the established production process to be transferred in parallel with process characterization resulting in accelerated deployment of a validated process. In addition to the rapid introduction and regulatory approval of the vaccine, Moderna has also responded to variants of concern by adapting to a platform process validation and qualification strategy to allow for rapid adaptation of this life-saving vaccine. These additional transfers and validations occur at an even further expedited rate to stay ahead of the continued observation of variants of concern.
    || [Immune Engineers: Harnessing the Full Potential of the Immune System]
    Speaker: Richard Gaynor
    mRNA is a versatile drug class which can be designed and optimized pharmacologically and immunologically, making it suitable for a broad range of applications such as prophylactic and therapeutic vaccines or protein substitutes. Its full potential may be harnessed when used in combination with other drug classes. BioNTech is working to provide effective treatments for different diseases, which is why we are leveraging four key drug classes – mRNA, cell therapies, small molecules, and antibodies – to enhance the immune system’s therapeutic potential. This presentation explores the synergistic benefits of mRNA in combination with other drug classes and explores the application of mRNA technology when combined with CAR T cell therapy for the treatment of specific oncology indications.
  • 1300 - 1415
    Lunch in Expo Hall
  • 1415 - 1600
    Expanding Your Footprint: Opportunities in Biotech presented by Women in Pharma®
    The biotechnology industry has changed as a result of the pandemic and has accelerated innovation at an unprecedented pace. As we evolve into a new era of biotechnology, the science and future scientific research will pioneer the pathway to cutting-edge technologies, modalities, and patient-centric therapies.   

    This collaborative Think Tank panel discussion, sponsored by Women in Pharma ®, will engage all conference attendees in a thought-provoking conversation about the future opportunities for the industry. Designed for everyone, regardless of their level of experience, this session will guide all participants to think of the future from a personal, professional, and industry level: From regulators and industry leaders to young professionals and students, collaboration and engagement between academia, research and development, and industry will be encouraged. All participants will have the opportunity to share new innovative ideas and gain insights to broaden their footprint as they either embark on or continue their pathway in this impactful and exciting industry.
    Session Leaders

    Prudence Edwards

    Double Degree Engineering Student (University of Queensland/Centrale Marseille)
    Speakers

    Jessica Beyer

    Director, Cell Therapy Manufacturing
    Bristol Myers Squibb
    Presentation Information
    [Panelists: ]
    Jessica Beyer, Bristol Myers Squibb
    Lindsey Daniel, Takeda
    Mahesh Karende, Omega Therapeutics
    Steffi Pluschkell, NIIMBL
  • 1600 - 1800
    Welcome Reception in Expo Hall
Day 2
Wednesday, 29 June 2022
  • 0700 - 1800
    Registration Open
  • 0730 - 0845
    Continental Breakfast
  • 0845 - 1015
    Concurrent Session: ATMPs/C&GT - Projects & Commercial Manufacturing
    The quality attributes of advanced therapy medicinal products (ATMPs) that correlate with safety and efficacy in patients are determined not only by manufacturing process inputs such as starting and raw materials, but also by how the manufacturing process itself is designed and controlled. To ensure regulatory compliance, the manufacturing process should therefore be developed based on thorough characterization of the ATMP during all stages of process and analytical development; this ensures that the critical quality attributes that correlate with safety and efficacy are identified and that their specifications can be met during routine manufacturing.  This session will include presentations exemplifying design, manufacturing and operation of the commercial manufacturing of medicinal products.
    Session Leaders

    Richard Denk

    Senior Consultant Aseptic Processing & Containment
    SKAN AG
    Speakers

    Ian Gaudet, PhD

    Senior Director and Site Head, San Jose Cell Manufacturing Facility
    Miltenyi Biotec

    Evan Lamb

    Product Specialist, ATMP Applications
    Skan US
    Presentation Information
    [Stay in Control: Strategies for Successful Cell Therapy Manufacturing]
    Speaker: Ian Gaudet, PhD
    Cell & Gene Therapy manufacturing success rates have historically been challenged by lack of process controls, with failures often undetected until final product release testing. Recently, process automation has improved manufacturing success among clinical programs by reducing human error. However, commercialization of mission-critical manufacturing requires improved processes robustness and additional in-process characterization and control to deliver these needed therapies consistently.
    || ["Why Should I Consider Continuous Manufacturing?"]
    Speaker: Robert Flynn
    Co-Speaker: Jeff Odum, CPIP
    As continuous manufacturing of biological products continues to grow, there is still reluctance around why to consider the technology as a manufacturing platform of choice within the industry. There are also a number of unique challenges to this type of manufacturing platform that present issues with many Development and Manufacturing organizations, challenges that often can represent a “deal killer” in terms of implementation. This presentation will focus on not just the pros/cons arguments of continuous manufacturing implementation, but also identify real world risks/challenges that have been seen and addressed, along with the motivation behind implementation. The product-process-facility enterprise will be discussed and how this platform has significant impact on these relationships.
    || [Important Considerations for Commercial Manufacturing of ATMPs]
    Speaker: Jordan Hjelmquist
    Co-Speaker: Evan Lamb
    The inability of some ATMPs to be terminally sterilized and sterility tested within the allowable product stability time frame has increased aseptic assurance requirements for the entire manufacturing process. Compounded with time sensitive cryopreservation operations, ATMP manufacturing presents a unique set of challenges that need to be addressed during initial process equipment and facility design to avoid costly delays and operational risk. This presentation will focus on the unique challenges of ATMP commercial manufacturing, and the way unique containment and vial technologies can address some of these challenges.
  • 0845 - 1015
    Concurrent Session: Enabling Digital Transformation(s) in Biotech
    With rapid advancements in data infrastructure and tools, the Biomanufacturing Industry is implementing new technologies and ways of working to accelerate the delivery of complex biotherapeutics to patients. These digital data transformations require connectivity between highly skilled SMEs in facilities design, equipment selection and validation, technology transfer, manufacturing operations, Quality Assurance, and Regulatory Authorities. This session invites case studies demonstrating the details and value of such digital transformations, including program acceleration, advanced data modeling, rapid technology transfer, enhanced operational readiness, and data-enhanced regulatory submissions.
    Session Leaders

    Prudence Edwards

    Double Degree Engineering Student (University of Queensland/Centrale Marseille)
    Speakers

    Fergal O'Neill

    Technical Solutions Consultant, Life Sciences
    Honeywell Process Solutions
    Presentation Information
    [Liquid Chromatography Digital Twin Framework]
    Speaker: Robert Zuban
    Herein, we present a liquid chromatography digital twin framework with an objective to facilitate real time monitoring, prediction, and optimization of chromatographic processes. By utilizing the digital twin framework, the necessary experiments carried out are limited to validation purposes only with significant impact on time to market and material cost.

    The fundamental parts of the liquid chromatography digital twin framework are:
    • Aspen Chromatography for simulation for design & optimization of chromatographic separation processes.
    • Design Expert for setting up the experimental protocol for obtaining cause and effect models.
    • Aspen Unscrambler for converting the simulations in Aspen Chromatography to statistical models based on the experimental protocol.
    • Aspen Process Pulse for utilizing the statistical models for performing monitoring and prediction (optimization would have been carried out in the offline mode) in real time.

    In this case study, the framework establishes a real time digital twin reflecting a liquid chromatography column that separates a mixture of an enantiomer of the essential amino acid D- and L-Threonine, yielding the optimal design based on several factors such as eluent flow rate, column height and particle radius.
    || [Applying Orchestration to Digitalize and Integrate Manufacturing Equipment]
    Speaker: Fergal O'Neill
    In trying to bring therapeutics and vaccines to market more efficiently, many manufacturers need to deal with legacy equipment. Many have “islands of automation” consisting of a variety of equipment and skids without an overarching supervisory system. As the need for speed and agility is greatly increasing, biotechnology production facilities need some way to better visualize and integrate batch processing across various equipment and systems.

    Control solutions enabled by ISA 88 batch in the controller are evolving to support more flexible engineering and agile process architecture. Process automation providers are making significant investments in solutions that intrinsically support flexible and modular manufacturing.

    Orchestration can help achieve centralized recipe management, real-time visibility across the entire process, and paperless batch reporting. It enables faster updates to existing facilities and helps make Pharma 4.0 a reality. Manufacturers can quickly scale up new systems, update existing infrastructure, and make agile changes to product formulation without replacing existing equipment.
    || [Predictive Computational Modeling of a 4,000L Single Use Bioreactor]
    Speaker: John Finch
    Co-Speaker: Colton Mitchell
    Computational Fluid Dynamics (CFD) modeling has been an effective tool for bioreactor design and scale up for years. An iterative approach of computational work and empirical testing is typically required to validate a CFD model that accurately predicts bioreactor performance across scales. To support scale-up of process intensified high-density cell culture, we have used M-Star CFD without iteration to develop a bioreactor model that closely correlates with empirical testing. In this session, we will present a study comparing computational results to empirical testing results for a 4,000L single use bioreactor. Measured and calculated blend time and mass transfer coefficient (KLa) data will be presented, as well as dynamic computational models showing real-time blending, shear, and velocity profiles. We will also show that the 4,000L single use bioreactor provides significant mass transfer capability to support high-density processing.
    || [Digitalization + Robust Automation = Pharma 4.0 Success!]
    Speaker: Yvonne Duckworth
    This presentation will discuss the advantages of a robust automation platform in conjunction with the overall benefits of implementing effective digital technologies in the Pharma 4.0 Journey. Some key elements of incorporating digital technologies include not only the value that is added and benefits to overall production, but understanding the impact on the design of a facility as well as the impact on the overall network infrastructure. This presentation will provide some easy-to-understand, practical and logical steps to consider when embarking on a Pharma 4.0 Journey, as well as build a roadmap for success.
  • 1015 - 1100
    Break in Expo Hall
  • 1100 - 1230
    Concurrent Session: ATMPs/C&GT - Data Science and R&D
    ATMPs and/or C&GT when applied to the world of Research and Development and Data Science require specific approaches compared to its manufacturing counterpart. Due to the small processing volumes, a Scale Out approach is implemented over a Scale Up approach. Unlike Mab therapy that begins from a Working Cell Bank, ATMPs begin with the patient itself and the variability of the starting material is what characterizes the uniqueness behind personalized medicine. The R&D efforts for ATMPs are focused on a five-dimensional framework where the “five R’s” incorporates notions regarding the right target, the right tissue, the right safety, the right patients, and the right commercial potential. This session invites attendees to explore novel and collaborative methods to achieve a consistent robust process in developing a sustainable, scalable manufacturing platform. Improvements in smart manufacturing of ATMPs/C&GT supported by AI tools, digitalization and data science are key drivers to scientific, technical and operational progress. Coupled with non-invasive sensors for process monitoring along with dynamic contamination control strategies, the pathway from bench scale to market through smart manufacturing of ATMPs becomes a more tangible reality.
    Session Leaders
    Speakers
    Presentation Information
    [The Rise of mRNA – The Impact of ATMP Modalities on the Industry’s Manufacturing Infrastructure]
    Speaker: Christian Lavarreda
    The preeminence of mRNA and viral vector-based vaccines in the COVID-19 pandemic response has begun reshaping the global biopharmaceutical manufacturing infrastructure. The number, speed, and scale of manufacturing investments in these COVID-19 vaccines reflect both the proven potential of ATMP modalities as well as the vast implications for bio-manufacturers as they seek to simultaneously meet current demand and future-proof their manufacturing infrastructure. This presentation will explain the new modalities, describe the specific processes involved in their production, and provide a perspective on the challenges involved in, and solutions needed for, successfully adapting today’s manufacturing infrastructure. This presentation is intended for those involved in the design, construction, and operation of biopharmaceutical facilities as well as researchers/scientists interested in understanding the impact of ATMP modalities on the pharma manufacturing industry.
    || [Global Expedited Programs for Cell and Gene Therapies]
    Speaker: Kimberley Buytaert-Hoefen, PhD
    Gene, cellular and tissue-based therapies hold tremendous promise for addressing some of the most problematic diseases, including those without treatment options and rare genetic conditions. Developers of these therapies should work with regulators beginning at the earliest stages of development. The interactions with regulators on how to design the development program allows for a facilitation of the approval process and ultimately bringing the treatment to the patients.
    || [Why AI and ATMP?]
    Speaker: Kevin Baughman
    ATMPs require specific controls and procedures when they are produced, unlike classic drug manufacturing. Characteristics like the inherent complexity around transforming biomaterial into personalized drugs, the variability of each batch highly dependent of multiple external factors and the need of not having margin for errors, make this new way to produce medicinal products an excellent scenario for AI. Techniques like dimension reduction, pattern recognition, anomaly detection and clustering are usually applied in biopharma manufacturing nowadays with outstanding results. The same principles are applicable to ATMP establishing the right redimension from a non-linear perspective. These approaches will be described during the presentation including use cases that would help to understand the benefits of this AI application.
    || [Drug Product Manufacture Challenges and Opportunities for Gene Therapy Products]
    Speaker: Lars Waldmann, PhD
    Co-Speaker: Dena Flamm
    Drug Product manufacture of gene therapy products is typically challenged by small batch sizes with limited ambient stability which requires expedient processing and measures to minimize product losses. Several case studies will highlight problems that occurred during manufacturing processes and how issues could be resolved by use of different components, procedural controls, or currently available technology. Other cases will be discussed where future technology may help to solve issues.

    While fill/finish technology has been developed to the needs of gene therapy by conserving product solution, the whole design of the single use flow path needs to be evaluated to minimize loss of product solution in the manufacturing process. Due to cold storage requirements, preferred materials for vials are ready-to-use non-glass components. Recent developments provide glass formulations suitable for cold storage applications. Maybe the availability of those new formulations will allow use of bulk glass vials for small batch sizes?

    Due to small batch sizes, not a lot of time remains during a fill to detect and correct equipment setup issues. Due to flexibility to support needs of clients, the equipment needs to frequently be changed over between different vial formats. How can a meaningful setup process be implemented that minimizes issues during the run? Some gene therapy products contain intrinsic proteinaceous particles. How can the visual inspection process be meaningful, and could future technologies help us distinguish between intrinsic and extrinsic particles? Sterile filtration of drug substance solution is a completely manual process. It requires creation of multiple flow paths and use of different instruments and connections.

    Despite theoretical and practical operator training, operators oftentimes lack confidence in performing this step. Could VR technology be helpful by providing operators with reference information while the tasks are being executed?
  • 1100 - 1230
    Concurrent Session: Process Intensification
    There has been a desire for increased efficiency in the manufacturing process to produce therapies with smaller markets.  Adoption of new technologies and methodologies can allow for such an evolution of manufacturing under the rubric of process intensification. There are various instances of implementation of process intensification in the biopharmaceutical industry.  This session will offer successful stories of several companies using this approach.
    Session Leaders
    Speakers

    Tapan Sanghvi

    Senior Director, Technical Operations
    Vertex Pharmaceuticals
    Presentation Information
    [Vertex’s CM Journey: From Business Case to Commercial Manufacturing]
    Speaker: Tapan Sanghiv
    Process intensification and continuous manufacturing have generated a lot of interest within pharmaceutical industry to bring therapies faster to market, increase productivity and make the most efficient use of production assets. This presentation will provide an overview of the business drivers that led to drug product continuous manufacturing at Vertex. Included will be considerations for developing process and control strategy, review of anticipated hurdles, surmountable challenges, and the unforeseen organizational benefits of implementing continuous manufacturing. In addition, general considerations for maximizing the operational efficiency of continuous manufacturing will be discussed.
    || [Automated Identification, Adaption and Deployment of Digital Twins to the Product Life Cycle]
    Speaker: Christoph Herwig, PhD
    Digital twins will play crucial role in continuous biomanufacturing, because product quality needs to ensure in a time continuum. Similarly, digital twins have the potential to accommodating uncertainties in ATMP starting material and albeit achieve constant product quality. For this, the digital twins need to be set up and also maintained in an efficient but also robust manner, so that they keep up with the evolution of the process life cycle. This contribution will show new workflows how to generate and adapt digital twins, as well how to deploy digital twins for upstream and downstream applications.
    || [Process Intensification and Continuous Manufacturing: Sanofi’s Transformational Journey]
    Speaker: Julie Barker
    Co-Speaker: Armin Opitz
    Process intensification and digitalization enable transformation in bioprocessing operations driving new facility design. In addition, the site’s Quality Management System must evolve to realize the benefits of process intensification in a next-generation facility, with consideration given to organizational design and governance, digital data management, and knowledge/learning management. This presentation walks through key principles and elements associated with realization of a digitally-enabled continuous bioprocessing facility, based on Sanofi’s experience with the launch and approval of its transformational facility that was awarded ISPE Facility of the Year in 2020.
  • 1230 - 1345
    Lunch in Expo Hall
  • 1345 - 1445
    ATMPs/C&GT Projects and Science: Panel Discussion and Q&A
    Speakers

    Ian Gaudet, PhD

    Senior Director and Site Head, San Jose Cell Manufacturing Facility
    Miltenyi Biotec

    Evan Lamb

    Product Specialist, ATMP Applications
    Skan US
    Presentation Information
    [Panelists: ]
    Ian Gaudet, Miltenyi Bio
    Jordan Hjelmquist, Pfizer
    Evan Lamb, SKAN US
    Jeff Odum, Genesis
    Robert Flynn, Sanofi
    Kevin Baughman, Aizon
    Christian Lavarreda, Syntegon Technology
    Kimberley Buytaert-Hoefen, Azzur Group
    Lars Waldmann, Thermo Fisher Scientific
    Dena Flamm, OPTIMA Pharma
  • 1345 - 1445
    Convergence of Digital Transformation and Process Intensification: Panel Discussion and Q&A
    Speakers
    Presentation Information
    [Panelists: ]
    John Finch, AZ
    Colton Mitchell, ABEC
    Robert Zuban, AspenTech
    Yvonne Duckworth, CRB
    Julie Barker, Sanofi
    Armin Opitz, Sanofi
    Tapan Sanghvi, Vertex Pharmaceuticals
    Christoph Herwig, Vienna University of Technology
  • 1445 - 1530
    Break in Expo Hall
  • 1530 - 1700
    Sustainability in the Biopharmaceutical Industry
    Environmental Sustainability considerations are being taken increasingly seriously by manufacturers, service providers, and regulatory agencies in the biopharmaceutical industry. This reflects rising awareness and development of technologies for reducing environmental impact worldwide. Recognizing the importance of reducing such impact, this session will include talks by three experts from the industry on topics such as decarbonization, single use technology, and lifecycle analysis (LCA). The session will also include a panel discussion which will respond to questions from the audience.  Attendees will come away with an understanding of current trends in sustainability in the Biopharmaceutical Industry, including a knowledge of tools such as LCA that can be applied to measuring environmental impact. Additionally, the session will highlight strategies to improve sustainability at both the facility and manufacturing process level.
    Session Leaders
    Speakers
    Presentation Information
    [Accelerating the Journey to Decarbonization]
    Speaker: Scott McVey
    The biotechnology and pharmaceutical industry has bold, ambitious carbon reduction targets; achieving these targets will take a long-term vision and a commitment to both immediate action and sustained transformation. We’ll break down specific steps that can be taken now, as well as present some exciting future technologies for which the sector should prepare to embrace on their Net Zero transformation journey.
    || [Environmental Sustainability in Single-use Materials]
    Speaker: William Whitford
    Biopharmaceutical manufacturing provides products of significant value in human health. Nevertheless, facility designers, suppliers, and entity sponsors are working to reduce its environmental footprint. New methods are reducing the environmental burden generated by single-use (SU) materials. Science-based approaches include environmental LCAs of the entire value chain, emerging environmental burden reduction technologies, and the digitally assisted rational design of solutions. Specific manufacturing solutions can be organized into the seven Rs: Rethink , Reduce, Reengineer, Reuse, Recycle, Recover, and Reduce. Rethinking includes if SU is appropriate for a specific operation, or reviewing the facility distance to SU materials supply or recycling vendors. An example of reduction is the shorting of a seed train, thereby eliminating some SU materials. Reengineering packaging to use recyclable materials, or less plastic, is popular. Reusing SU materials in-house has been accomplished, e.g., employing a sterile fluid material container to collect intermediate product. There are new approaches to recycling, including those supporting more circular economies. Recovering energy through advanced incineration is popular, and reduction of discard from exceeding expiry dates in inventory is alleviated through advanced supply chain methods. Finally, the employment of building information modeling (BIM) systems aids in developing life cycle-based project designs and asset selection.
    || [Environmental Impact of Biopharmaceutical Manufacturing Using Carbon Footprint Models and Life Cycle Assessments]
    Speaker: Phillip Smith
    Through the use of carbon footprint and life cycle assessment (LCA) tools, essential data and information for biopharmaceutical manufacturing operations are obtained that can inform key decisions for product, process, and plant design. Discussion on the scope boundaries and the primary drivers that impact the assessments will be discussed.
    || [Environmental Impact of Biopharmaceutical Manufacturing Using Carbon Footprint Models and Life Cycle Assessments]
    Speaker: Daniel D'Aquila, PE
    Through the use of carbon footprint and life cycle assessment (LCA) tools, essential data and information for biopharmaceutical manufacturing operations are obtained that can inform key decisions for product, process, and plant design. Discussion on the scope boundaries and the primary drivers that impact the assessments will be discussed.
Day 3
Thursday, 30 June 2022
  • 0700 - 1100
    Registration Open
  • 0730 - 0930
    Mix and Mingle Networking Breakfast in Expo Hall
  • 0930 - 1030
    Executive Panel: Risk Management for Future Disruptions
      The pandemic has illuminated a new dimension of crisis management, collaborations, and unification of our industry to provide healthcare and support to the world in a crisis .  The future operating models for our industry need to have resilience and risk management strategies to prepare, address and manage potential points of failure and vulnerabilities to drive success and address future disruptions and risk scenarios as a result of the pandemic.    There is a fundamental shift  in exposures to risk and vulnerabilities in the areas of cybersecurity, supply chain and regulatory compliance concerns. Join us as our industry leaders discuss opportunities, threats, and areas of continual growth for risk management readiness for our evolving exposures in the world.
    Session Leaders

    Prudence Edwards

    Double Degree Engineering Student (University of Queensland/Centrale Marseille)

    Tanya Sharma

    Partner At Assurea, Steering Committee Women in Pharma
    Assurea, LLC
    Speakers

    Scott W. Billman

    Vice President, Engineering, Pharmaceutical Services
    Thermo Fisher Scientific
    Presentation Information
    [Panelists:]
    Nilanjan Banerjee, PhD, UMBC
    Scott Billman, Thermo Fisher Scientific
    Marco Cacciuttolo, PhD, Novavax
    Norman Goldschmidt, Genesis AEC
    Oliver Hennig, PhD, BioNTech SE
    Seneca Toms, U.S. Food and Drug Administration (FDA)
  • 1030 - 1045
    Break
  • 1045 - 1130
    Closing Keynote Session
    Session Leaders
    Speakers

    Juan Andres

    Chief Technical Operations and Quality Officer
    Moderna Inc.
    Presentation Information
    [Ideas to Performance: The impossible journey]
    Speaker: Juan Andres
    Moderna’s Chief Technical and Quality Officer discusses the company’s journey from start-up to scale-up, overcoming challenges, and moving into the future. Included in this presentation will be Moderna’s pre-pandemic background, COVID preparation and operations insights, executing against the plan, and the company’s future operations.
  • 1130 - 1145
    Closing Remarks and Adjourn
  • 1215 - 1700
    ElevateBio Facility Tour
    Registration and $25 fee required. Space is limited.

    ElevateBio, BaseCamp is a Center of Innovation for ElevateBio. ElevateBio provides the tools, time, and environment where researchers can innovate, develop, and accelerate life-transformative therapies. The team at BaseCamp has years of experience in cell and gene therapy process development and manufacturing. They have developed a toolbox of unit operations that can be used to rapidly translate cell and gene therapy products allowing them to enter the clinic quickly and at a lower cost that tradition cell and gene-based therapies.  ElevateBio BaseCamp – the heart of our operations – is a dedicated cell and gene therapy research, process development, and production center that addresses the primary obstacles in cell and gene therapy and regenerative medicine: integrated research, process development and manufacturing.

    For more information, visit https://www.elevate.bio/basecamp.

    Visitors will be provided lunch and a brief overview presentation of the facility and the areas of the walking tour.

    The tour will provide guests, in small groups, with a view of the ‘Science on Display’ operations and will pass by the research and development for immunotherapy, regenerative medicine, and cell therapy laboratories.  Process development laboratories and scaled manufacturing capabilities for rapid translation of processes will be discussed and cGMP manufacturing with industry leading product development know-how for the manufacturing of viral vectors and cell therapies will also be reviewed.  The tour will not include access to the clean room space, but windows making viewing possible.

    Tour Guidelines / Restrictions - Proof of COVID vaccination is required.
    Any additional COVID guidance requirements will be updated as the event approaches.

    - All tour guests must wear closed toe shoes for safety purposes.

    - Photography/Video recording is not permitted.
  • 1215 - 1700
    Sanofi Facility Tour
    Registration and fee required. Space is limited.

    Sanofi’s new facility and the implementation of integrated continuous biomanufacturing is an innovative breakthrough and the first step towards achieving the full potential of continuous processing technologies. The facility is the most advanced digitally integrated manufacturing facility in the Sanofi network and the world’s first using continuous biomanufacturing for commercial biologics production. Sanofi has utilized new and innovative technologies to improve the quality of their products, made manufacturing more efficient and environmentally friendly, and reduced the time required to deliver the highest quality medicines to patients.

    Sanofi’s digital manufacturing facility in Framingham, US, received the 2020 Facility of the Year Award in the Facility of the Future category from the International Society for Pharmaceutical Engineering (ISPE), highlighting Sanofi as a game changer for the future.

    For more information, visit: https://www.sanofi.com/en/about-us/our-stories/sanofi-takes-a-step-into-the-future-of-making-medicine. 

    Visitors will be provided lunch and a brief overview presentation highlighting key elements of facility design and operations.  Following the presentation, visitors, in small groups, will be invited to take a walking window-tour to view various operational manufacturing areas from outside the controlled classified areas and will be provided access to many of the facility’s mechanical areas.  The tour will provide a high-level overview of facility design and highlight design decisions made for flexibility and maintainability.  A brief demonstration of the digital technologies that enhance the flexibility of the facility will also be presented. This visit will provide highlights as to how Sanofi approached the challenges of implementing these new technologies in a commercial manufacturing environment.  As this facility is an active cGMP commercial operation, access into controlled classified areas will not be provided and visitors will need to be comfortable climbing multiple flights of stairs to participate in the walking tour. 

    Tour Guidelines / Restrictions  - Proof of COVID vaccination is required.
    Any additional COVID guidance requirements will be updated as the event approaches. 

    - Sanofi-issued badges must be worn and visible at all times. 

    - All tour guests must wear closed toe shoes for safety purposes. 

    - Photography/Video recording is not permitted.  No cameras of any kind are allowed.  Use of smart phones while walking, around campus, or inside buildings, is prohibited. 

    - All visitors must adhere to all safety signs and guidance.