Resources
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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
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CMC Strategy Forum North America 2025 Summary Infographic
Summary Infographic: CMC Strategy Forum North America 2025
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Establishment of Specifications for Monoclonal Antibodies
Speaker Presentation: CMC Strategy Forum Japan 2024
Yu Chuanfei, NIFDC, 2024 -
ICH Q6 Revision Towards Globally Harmonized Specifications
Speaker Presentation: CMC Strategy Forum Japan 2024
Yamaguchi Takahiro, JPMA, 2024 -
Challenges in the Clinical Implementation of piggyBac Transposon Mediated CAR-T Cell Therapy
Speaker Presentation: CMC Strategy Forum Japan 2024
Yagyu Shigeki, A-SEEDS, 2024 -
Role of ICH Q2/Q14 and ICH Q6 on Establishment of Control Strategy
Speaker Presentation: CMC Strategy Forum Japan 2024
Shibata Hiroko, PMDA, 2024 -
Regulatory Updates and a Perspective on Biopharmaceuticals in Japan
Speaker Presentation: CMC Strategy Forum Japan 2024
Sakurai Akira, PMDA, 2024 -
Expectations for ICH M4Q(R2) from an Industry Point of View
Speaker Presentation: CMC Strategy Forum Japan 2024
Ohtsuka Hiroshi, Bayer Yakuhin, Ltd., 2024 -
Quality Control of the Raw Materials for Cell and Gene Therapy Products
Speaker Presentation: CMC Strategy Forum Japan 2024
Nishikawa Atsushi, PMDA, 2024 -
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
Speaker Presentation: CMC Strategy Forum Japan 2024
Markovic Ingrid, CBER, FDA, 2024 [Session IV] -
ICH Efforts Towards Developing a Unified ICH Q6 Guideline and Modernizing Global Standards for Specifications Setting
Speaker Presentation: CMC Strategy Forum Japan 2024
Markovic Ingrid, CBER, FDA, 2024 [Session III] -
Update on the Initiatives at the Center for Biologics Evaluation and Research (CBER), U.S. FDA
Speaker Presentation: CMC Strategy Forum Japan 2024
Markovic Ingrid, CBER, FDA, 2024 [Session I]