Resources
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How Industry and Regulatory Innovation and Collaboration Can Promote the Transition From in Vivo to in Vitro Potency Testing for Human Legacy Vaccines
Speaker Presentation: WCBP 2025
Coppens Emmanuelle, Sanofi, 2025 -
Bacterial Endotoxin Testing: Progressive Science and Sustainability
Speaker Presentation: WCBP 2025
Bolden Jay, Eli Lilly and Company, 2025 -
Considerations for Developing an Autoinjector Control Strategy: A Case Study
Speaker Presentation: WCBP 2025
Benokraitis Kristin, Biogen, 2025 -
Replacement of in vivo
Immunogenicity Assay with
in vitro Antigenicity ELISA
for Pertactin Antigen in
Acellular Pertussis
Combination Vaccines
Speaker Presentation: WCBP 2025
Ljutic Belma, Sanofi, 2025 -
What Do Crabs Have to Do with Birds Have to Do with People?
Speaker Presentation: WCBP 2025
Bamford Holly, National Fish & Wildlife Foundation, 2025 -
How to Effectively Manage CMC Post-Approval Changes
Speaker Presentation: WCBP 2025
Armando John, Genentech, a Member of the Roche Group, 2025 -
Practical and Regulatory Considerations for Machine Learning Models Applied to Process Development and Control
Speaker Presentation: CMC Strategy Forum North America 2025
Stevens Ben, GlaxoSmithKline, 2025 -
Enhanced Approaches Support Robust Harmonized Vaccine Potency Specifications
Speaker Presentation: CMC Strategy Forum North America 2025
Smith Dean, Health Canada, 2025 -
Regulatory Expectations for Data Models to Support a Marketing Application
Speaker Presentation: CMC Strategy Forum North America 2025
Siggers Jayda, Health Canada, 2025 -
Enhanced Approaches to Setting Specifications – A Regulatory Perspective
Speaker Presentation: CMC Strategy Forum North America 2025
Siggers Jayda, Health Canada, 2025 -
Development of Realistic and Safe AI/ML Applications for Biotherapeutic Characterization and Process Development
Speaker Presentation: CMC Strategy Forum North America 2025
Shaver Jeremy, Pfizer, Inc., 2025 -
What Is Meant by Patient-Centric Quality Standards?
Speaker Presentation: CMC Strategy Forum North America 2025
Krause Phil, Independent Consultant, 2025 -
Case Studies for Patient-Centric Specification Setting for a Therapeutic Protein and IQ Readout on Endotoxin Acceptance Criteria Part 1
Speaker Presentation: CMC Strategy Forum North America 2025
Kearns Katrina, Pfizer, Inc., 2025 -
Empowering 5.0 BioSolutions Through Realtime PAT and Computational Controls
Speaker Presentation: CMC Strategy Forum North America 2025
Botonjic-Sehic Edita, ReciBioPharm, 2025 -
Leveraging Biotransformation Data to Refine Bioprocesses and Derisk PQAs
Speaker Presentation: CMC Strategy Forum North America 2025
Beaumont Maribel, Eli Lilly and Company, 2025 -
AI-Accelerated Stability for Biologics
Speaker Presentation: CMC Strategy Forum North America 2025
Bayrak Seyma, Amgen Inc., 2025 -
The Challenge and Criticality of Data Contextualization to Support Effective AI/ML/Modeling in Bioprocess Development – an Industrial Case Study
Speaker Presentation: CMC Strategy Forum North America 2025
Airiau Christian, Sanofi, 2025 -
WCBP 2025 Summary Infographic
Summary Infographic: WCBP 2025
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WCBP 2025 Scientific Program
Scientific Program: WCBP 2025
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CMC Strategy Forum North America 2025 Scientific Program
Scientific Program: CMC Strategy Forum North America 2025