Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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Manufacturing - Quality Control & Operational Excellence
Mon, 27 Oct
Tue, 28 Oct
1045 – 1115
Manufacturing - Quality Control & Operational Excellence
Wei Huang, Henlius Biopharmaceutical Ltd
Advancements in biologics manufacturing and quality control have driven the development of novel technologies aimed at improving efficiency, consistency, and safety in the production of therapeutic biologics. The speaker will present some of the recent developments in continuous bioprocessing and real-time analytics. The integration of artificial intelligence (AI) into process optimization and predictive analytics to improve manufacturing operation excellence. The impact of these technologies on scalability, cost-effectiveness, and regulatory compliance is also examined, highlighting their role in meeting the growing demand for biologics. As these innovations continue to evolve, they promise to further streamline production processes and improve the quality and accessibility of biologic therapies.
1115 – 1145
Manufacturing - Quality Control & Operational Excellence
Line Lundsberg-Nielsen, NNE
Toby Groathouse, Novo Nordisk
Joseph Jerkins, Genentech
In the evolving pharmaceutical manufacturing landscape, Novo Nordisk and Roche have collaborated to enhance production capacity and agility through innovative approaches. This presentation focuses on "Fleet Management" and its potential to reshape the regulatory framework for Distributed Manufacturing. The industry is at a critical juncture, requiring a transition from traditional centralized models to dynamic decentralized systems. Our efforts highlight the significance of digitally connected, standardized facilities within a global network, grounded in harmonization and enhanced connectivity to ensure consistency and quality. The Fleet Management framework introduces a standardized method for managing equivalent manufacturing systems that can be replicated across locations. This presentation will discuss our development of the Fleet concept and its influence on a global Pharmaceutical Quality System. At Novo Nordisk, we are creating a fill & finish manufacturing network to swiftly respond to patient demands. The Fleet Management concept, with standardized manufacturing equipment and real-time monitoring, supports a data-driven performance program. At Roche, the fleet concept has been deployed to a multi-component parenteral packaging platform, enhancing operational efficiency. These initiatives demonstrate how embracing distributed manufacturing can create a more responsive and sustainable pharmaceutical production landscape. Collaboration among regulators and industry stakeholders is essential to implement this innovative framework.
1145 – 1215
Manufacturing - Quality Control & Operational Excellence
Celeste Frankenfeld Lamm, Merck & Co Inc
manufacturing and 3D printing, and the rise of personalized medicine. Modular small-scale production systems are particularly suited to cell and gene therapies and other advanced medicinal products that cater to patient-specific treatments. While significant progress has been made in terms of technological innovation, the enabling of these new manufacturing models and commercial adoption remains limited mainly to regulatory and economic barriers. The ISPE PQLI Transportable/POC Committee was established in 2021 with the purpose of collecting information and assessing the industry landscape with regard to the technologies, best practices, challenges, and regulatory thinking that all impact the realization of these manufacturing platforms. In parallel, over the past few years, regulatory agencies including FDA, MHRA, and EMA have engaged industry and published proposals/papers as part of their effort to initiate dialogue in support of the development of regulatory guidelines. The session intends to provide an industry update based on the activities and findings generated by the PQLI committee.
1345 – 1415
Manufacturing - Quality Control & Operational Excellence
Jason Schneider, AbbVie Inc
Robert Perks, Performance Validation, Inc.
As the biopharma and medical device industries embrace Pharma 4.0TM and Artificial Intelligence and acknowledge their necessity as competitive advantages in an increasingly competitive environment, there are still many fundamentals that are overlooked in the successful deployment of these applications. This presentation will examine the practical requirements for the successful deployment of Pharma 4.0TM and Artificial Intelligence into the manufacturing environment. The presentation will include real-world examples that demonstrate the holistic approach necessary to ensure both successful and sustainable deployment of applications and initiatives that provide real solutions to problems. The understanding of the problem that is being addressed, the workforce requirements, and preparation are as important, if not more so, than the technology being deployed. The presentation will also guide the audience through the steps required to not only ensure a successful outcome but to also provide a framework that can be defended at an audit. Understanding the problem, determining the business value and ROI, AI data readiness, testing strategies, maintenance and monitoring, and, ultimately, audit readiness.
1415 – 1445
Manufacturing - Quality Control & Operational Excellence
Matthew Foster, Eli Lilly
As a greenfield site, Lilly RTP (Research Triangle Park) is the first flagship of Lilly’s facility modernization investment to meet a growth period of new innovative medicines and rapid demand. Lilly RTP was designed first with speed and innovation at the forefront. It includes the most modern aseptic filling and inspection technology, high-speed device assembly and packaging, and automatic material movement. The facility was designed with a digital-first mandate as a 100% paperless plant; this includes fully integrated electronic batch records integrating all material operations, and a suite of digital integrated tools to oversee all plant operations. From dock to dock, there is no manual handling; materials are moved by automatic conveyance, robotic palletization, and automatic guided vehicles which exactly pick and place all material movements directly to the production line. As a result of this technology integration, Lilly RTP was able to ramp quickly and achieve a high-volume reliable supply of medicines. This technology integration has quickly demonstrated value through improved safety, human error reduction, and productivity.
1445 – 1515
Manufacturing - Quality Control & Operational Excellence
Philippe Cini, PhD, A-connect
In this presentation, the author will introduce a systematic, practical, and fast methodology to achieve quantitative process understanding and control using primarily sparse historical data from either development or commercial manufacturing. Through recent case studies, the author will show how, in one instance, this approach that combines advanced modeling and expert knowledge successfully addressed late-stage development process deficiencies and in another instance led to the elimination of stability issues in a very complex investigation of a commercial product. The author will make the case to use historical data for modeling even when those datasets are incomplete and highly not normal. The insight created can be quite powerful and it is a lot faster and cheaper than generating new data. Generating new data should be a last resort or rather used in a focused way to verify/confirm the findings achieved through mining and analysis of historical data. The author will also share how those innovative data-driven approaches can benefit greatly from today's digital capabilities to further enhance them and make them more readily applicable.
1615 – 1645
Manufacturing - Quality Control & Operational Excellence
1645 – 1715
Manufacturing - Quality Control & Operational Excellence
Erwan Levesque, Sanofi
Explain how Engineering, at the global and site level within Sanofi Manufacturing & Supply, is embracing a new operating model at scale in facilities management, asset management, automation, and project delivery with the leveraging of the size & footprint of the company, new technologies, new way of working and ecosystem. Explain as well how we will use this opportunity to work as collective intelligence within engineering & maintenance teams and associated internal and external stakeholders. Explain as well how we design an organization supporting talent density/development and fluid transitions (both ways) between sites, regions, and global or large project management positions.
1715 – 1745
Manufacturing - Quality Control & Operational Excellence
Sajida Roberson, Independent Consultant
The pharmaceutical industry is growing more complex, requiring agile, data-driven operations to maintain efficiency and quality. To remain competitive, companies must simplify how they manage internal and external ecosystems while upskilling their workforce to meet evolving industry demands. Astellas Pharma has expanded rapidly through strategic acquisitions and investments in cutting-edge research and manufacturing hubs. This growth led to fragmented processes, inconsistent requirements, and operational complexity. It also underscored the need for talent with expertise in supply chain management, provider partnerships, and operations across both small molecules and advanced modalities. To address these challenges, Astellas implemented the Strategic Outsourcing and Relationships (SOAR) Model—an operating framework that simplifies operations, strengthens provider partnerships, and builds leadership capabilities while improving efficiency. SOAR integrates center-led coordination with localized execution, optimizing provider relationships, upskilling talent, and driving operational excellence. This session explores SOAR’s scalable framework that is a catalyst for operational transformation and how at Astellas it:
- Developed leaders with critical supply chain and operational expertise- Enhanced organization agility, strengthened resiliency, and fostered change readiness
- Aligned research and early-stage manufacturing strategy with operational realities post-acquisition
- Optimized provider partnerships to improve efficiency, quality, and compliance- Simplified requirements and reduced administrative burdens.
- Developed leaders with critical supply chain and operational expertise- Enhanced organization agility, strengthened resiliency, and fostered change readiness
- Aligned research and early-stage manufacturing strategy with operational realities post-acquisition
- Optimized provider partnerships to improve efficiency, quality, and compliance- Simplified requirements and reduced administrative burdens.
1030 – 1100
Manufacturing - Quality Control & Operational Excellence
Paul Lopolito, Steris Corporation
Equipment cleaning concerns are often overlooked during the design, startup, and commissioning of biopharmaceutical facilities. Failures to understand cleaning agent selection, critical cleaning parameters, drug product degradation, analytical method recovery factors, and stainless-steel maintenance strategy can lead to costly delays in the process. Technical transfer teams and regulatory agencies expect laboratory testing to support the cleaning validation lifecycle approach. This presentation will explore a case study incorporating routine cleaning evaluation, air-liquid interface residue cleaning strategy, total organic carbon recovery, drug product degradation, and stainless-steel maintenance testing. The samples evaluated included drug products, inorganic buffers, organic buffers, and media. This valuable information obtained during the design transfer stage enabled the manufacturing process team to focus on the later stages of cleaning qualification and monitoring.
1100 – 1130
Manufacturing - Quality Control & Operational Excellence
Steven Ng, AST Inc
This technical presentation will present the development and use of 7% Vapor Phase Hydrogen Peroxide (VPHP) for decontamination in aseptic isolators and includes design considerations, validation protocols, and data points across multiple isolated filling line configurations. Effective decontamination protocols utilizing hydrogen peroxide are standard to sterility strategies but pose significant challenges to aseptic processing operations. These challenges include extended operational downtime due to application methods, and high-concentration limitations and risks. Conventional methods using high-concentration VPHP also incur risks to personnel and sensitive equipment with measurable absorption and long periods of off-gassing, which have largely been considered necessary consequences of achieving sterility assurance. Recent advancements in decontamination technology, however, have focused on process, efficiency, and safety improvements that are both regulatorily robust and consider manufacturing realities around new products like highly targeted, time-sensitive liquid pharmaceuticals. One such advancement is the use of low-concentration rapid VPHP technology for a complete 1-hour cycle time, including aeration. In this presentation, validation data will be used to evaluate the efficacy of low-concentration, low-volume VPHP in achieving >6-log reduction, mitigating outgassing (PPM over time), expanding material compatibility, and reducing machine downtime in an automated fill-finish setting.
1130 – 1200
Manufacturing - Quality Control & Operational Excellence
Jörg Zimmermann, Vetter Pharma Fertigung GmbH & Co KG
Enhancing Sterility Assurance: Integrating Automated H2O2 Decontamination in RABS Cleanrooms
RABS and Isolators are described as appropriate technologies in Annex 1. By upgrading existing clean rooms to an automated H2O2 decontamination system, the advantages of both systems can be combined, resulting in superior sterility assurance. In this presentation, we will showcase the technical installation, qualification, and implementation of this technology in new and existing RABS clean rooms. This includes also the aspects of analytical methods to test for residual H2O2, both in the air and the filled product. Data from the last 8 successful years of operation will be shared. Attendees will get insights into the design, installation, qualification, and operation of automated decontamination of RABS clean rooms.
RABS and Isolators are described as appropriate technologies in Annex 1. By upgrading existing clean rooms to an automated H2O2 decontamination system, the advantages of both systems can be combined, resulting in superior sterility assurance. In this presentation, we will showcase the technical installation, qualification, and implementation of this technology in new and existing RABS clean rooms. This includes also the aspects of analytical methods to test for residual H2O2, both in the air and the filled product. Data from the last 8 successful years of operation will be shared. Attendees will get insights into the design, installation, qualification, and operation of automated decontamination of RABS clean rooms.
1545 – 1630
Manufacturing - Quality Control & Operational Excellence
Jeffrey Heil, Arcadis
Matthew Pelletier, Nitto Denko Avecia
Joe Laviano, PE, Arcadis
Curating a state-of-the-art manufacturing facility to meet a present demand is no easy feat – even more so is the complexity of designing and constructing a facility that needs to be equipped to thrive in a rapidly growing sector for decades to come. How can teams successfully navigate the push-and-pull of “how much do we build now to be ready to mobilize?” against the unknown of “how seamlessly can we implement future improvements to stay on the cutting edge?” 2025 FOYA Finalist Nitto Avecia, who recently completed their new M5 Facility Expansion in Milford, MA, had to weigh both sides when designing and constructing the largest oligonucleotide CDMO in the US. This panel will include team members (both engineers and end users) who were both critical to the success of the new facility and continue to spearhead initiatives that will keep the facility innovative and robust moving forward.
1630 – 1715
Manufacturing - Quality Control & Operational Excellence
Alex Gadberry, AstraZeneca
Nicholas Guros, AstraZeneca
There is an increasingly urgent need to reduce the cost of goods and manufacturing (COGM) and to expand the manufacturing capacity of biopharmaceuticals, demonstrated by an increase in the development of new therapies concurrently with the limitations of existing fed-batch facilities. In this work, we propose a solution to this manufacturing dilemma: Integrated Dynamic Bioprocessing (IDB). Herein, we define IDB as a fully integrated, continuous, dynamic process where throughout the stages of cell growth clarified upstream material is continuously sent downstream for purification at varying titer concentrations. Note: downstream processing details are out of the scope of this work. The goal of IDB is to increase productivity over fed-batch processing (FB) by five-fold using the same bioreactor footprint and working volume. We have demonstrated this successfully at the 250 mL, 3 L, and 50 L bioreactor scales, and in this work we report the success of the 500 L clinical scale, discussing the significant scale-up challenges compared to the smaller scales. Firstly, the bioreactor was designed to sustain the required cell density (> 120 M cells/mL) to achieve this titer increase - enabling high oxygen mass transfer and mitigating the impact of the deleterious effects of cell shearing, pCO2 accumulation, foam build-up, or exhaust filter fouling. Secondly, continuous clarification was achieved using tangential flow filtration (TFF). The pilot scale required the use of numerous TFF hollow fiber filters to provide adequate surface area for filtration of the high cell density culture, ultimately requiring novel model predictive control and filter transition strategies to meet the filtration requirements of the process. Lastly, a Raman-based feeding strategy was required to dynamically respond to the glucose consumption dynamic cell culture process. Herein, we present our success in significantly increasing titer over fed-batch bioprocessing while maintaining important product quality metrics.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.