Resources
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Enabling the Future of Biopharmaceutical Manufacturing Through Collaborative Innovation
Speaker Presentation: WCBP 2026
Myers Riley, NIIMBL, 2026 -
Overcoming Barriers to local GMP
Manufacturing and testing in LMICs:
Doing Things we never had
Speaker Presentation: WCBP 2026
Makhoana Morena, Biovac, 2026 -
Use of Predictive Stability for Shelf-Life Extension, ICH Q1 Annex 2
Speaker Presentation: WCBP 2026
Lemieux Linda, Merck & Co., Inc., 2026 -
Visible Particle Control in Biologics and Advanced Therapy Products: Challenges, Case Studies, and Evolving Expectations
Speaker Presentation: WCBP 2026
Koulov Atanas, Clear Solutions Laboratories AG, 2026 -
Integrating Artificial Intelligence into Pharmaceutical Manufacturing
Speaker Presentation: WCBP 2026
Kiang Tina, CDER, FDA, 2026 -
Controlling Particulate Matter in Ophthalmic Biologics; Establishing a Risk-Based Analytical Approach to Sub-Visible Particulates
Speaker Presentation: WCBP 2026
Jones Lauren C, Regeneron Pharmaceuticals Inc., 2026 -
Building a Resilient Commercial Supply Chain for Antibody-Drug Conjugate Products: A Risk-Based Comparability Approach
Speaker Presentation: WCBP 2026
Jagani Dipkumar, Astellas Pharma US, Inc., 2026 -
No AI Without
Architecture: FHIR
as the Data
Foundation
Speaker Presentation: WCBP 2026
Hyttel Kåre, NNIT A/S, 2026 -
Machine Learning-Supported (Process) Models: Promises and Practical Implementation Challenges
Speaker Presentation: WCBP 2026
Heinlein Christina, Genentech, a Member of the Roche Group, 2026 -
Code, Care, and Conscience: How AI, Ethics, and Lived Experience Are Redefining the Future of Pharma
Speaker Presentation: WCBP 2026
Hayes-Mota Guadalupe, Santa Clara University, 2026 -
Side-by-Side Stress Studies Designed to Support Post-Change Shelf Life
Speaker Presentation: WCBP 2026
Flick Tawnya, Gilead Sciences, Inc., 2026 -
International Collaboration and Reliance
Speaker Presentation: WCBP 2026
Dooley Brian, European Medicines Agency, 2026 -
Insights to Industry Led CMC PAC Reliance Pilots on Behalf of EFPIA
Speaker Presentation: WCBP 2026
Ban Cynthia, Sanofi Pasteur Limited Canada, 2026 -
Keynote Session III - The Heart of Innovation: Patients Shaping the Future of Biologics
Speaker Presentation: WCBP 2026
Abernathy Michael, Amgen Inc., 2026 -
30th Anniversary Workshop: Pet Peeves and Roadblocks in CMC: Improving your Quality Submissions through the Product Lifecycle Redux – The 2026 Version
Speaker Presentation: WCBP 2026
Marjorie Shapiro, Chana Fuchs, 2026 -
Vaccine Specific Regulatory Considerations
Roundtable Notes: Session 2 Table 9 WCBP 2026
Vaccine Specific Regulatory Considerations -
Vaccine Potency - Compare and Contrast Potency Tests for Different Vaccine Modalities
Roundtable Notes: Session 2 Table 2 WCBP 2026
Vaccine Potency - Compare and Contrast Potency Tests for Different Vaccine Modalities -
Using Accelerated Degradation Studies to Support Comparability Assessments
Roundtable Notes: Session 2 Table 13 WCBP 2026
Using Accelerated Degradation Studies to Support Comparability Assessments -
Use of Machine Learning (ML) and Artificial Intelligence (AI) in Content Creation of Early Phase Development and Managing Submissions and Information Requests with Health Authorities
Roundtable Notes: Session 1 Table 16 WCBP 2026
Use of Machine Learning (ML) and Artificial Intelligence (AI) in Content Creation of Early Phase Development and Managing Submissions and Information Requests with Health Authorities -
Use of Chromatography Resins Across Multiple Products
Roundtable Notes: Session 1 Table 11 WCBP 2026
Use of Chromatography Resins Across Multiple Products