Resources
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Black Box, Fantasy, or Gödel’s Knot? Why Mass Spectrometry in Biopharma is None of These
Speaker Presentation: Consultants' Network March 2025
Skilton St John, Protein Metrics, LLC, 2025 -
Case Study:
Investigating
Monoclonal Antibody
Fragmentation Issues
Speaker Presentation: Consultants' Network March 2025
Schenerman Mark, CMC-MAS Biotech, 2025 -
Managing/Leveraging CMOs and CTOs for Lifecycle Success [Session 1]
Roundtable Notes: Session 1 Table 7 WCBP 2025
Managing/Leveraging CMOs and CTOs for Lifecycle Success [Session 1] -
Wide-Spread Adoption of High-Volume Delivery Subcutaneously - What’s the Hold-Up
Roundtable Notes: Session 1 Table 15 WCBP 2025
Wide-Spread Adoption of High-Volume Delivery Subcutaneously - What’s the Hold-Up -
What Are the New Alternate Lipids for Lipid Nanoparticles
Roundtable Notes: Session 1 Table 17 WCBP 2025
What Are the New Alternate Lipids for Lipid Nanoparticles -
Vaccine Manufacturing New Technologies for mRNA Production
Roundtable Notes: Session 2 Table 15 WCBP 2025
Vaccine Manufacturing New Technologies for mRNA Production -
The Road to One Global CMC Dossier [Session 1]
Roundtable Notes: Session 1 Table 5 WCBP 2025
The Road to One Global CMC Dossier [Session 1] -
The Road to One Global CMC Dossier [Session 2]
Roundtable Notes: Session 2 Table 5 WCBP 2025
The Road to One Global CMC Dossier [Session 2] -
Tech Transfer Challenges and How to Avoid Common Mistakes
Roundtable Notes: Session 2 Table 17 WCBP 2025
Tech Transfer Challenges and How to Avoid Common Mistakes -
Setting Specifications on Limited Data, Clinically
Relevant Specs/ Next Generation Control Strategies: Looking Ahead to Revision of ICH
Q6B
Roundtable Notes: Session 1 Table 1 WCBP 2025
Setting Specifications on Limited Data, Clinically Relevant Specs/ Next Generation Control Strategies: Looking Ahead to Revision of ICH Q6B -
Setting Specification (Including Potency) for Not Well-Characterized Biological Products, e.g., Cell and Gene Therapy Products [Session 2]
Roundtable Notes: Session 2 Table 1 WCBP 2025
Setting Specification (Including Potency) for Not Well-Characterized Biological Products, e.g., Cell and Gene Therapy Products [Session 2] -
Relevance of Accelerated and Forced Degradation Studies for a Frozen DS DP [Session 1]
Roundtable Notes: Session 1 Table 6 WCBP 2025
Relevance of Accelerated and Forced Degradation Studies for a Frozen DS DP [Session 1] -
Relevance of Accelerated and Forced Degradation Studies for a Frozen DS DP [Session 2]
Roundtable Notes: Session 2 Table 6 WCBP 2025
Relevance of Accelerated and Forced Degradation Studies for a Frozen DS DP [Session 2] -
Recent Trends in Questions from Global Health Authorities [Session 1]
Roundtable Notes: Session 1 Table 3 WCBP 2025
Recent Trends in Questions from Global Health Authorities [Session 1] -
Recent Trends in Questions from Global Health Authorities [Session 2]
Roundtable Notes: Session 2 Table 3 WCBP 2025
Recent Trends in Questions from Global Health Authorities [Session 2] -
Practical Applications of AI and ML in Discovery, Development and Platform Establishment Including CQA Controls
Roundtable Notes: Session 1 Table 13 WCBP 2025
Practical Applications of AI and ML in Discovery, Development and Platform Establishment Including CQA Controls -
Navigating 2-Tier Reference Standard Strategy for Biologics
Roundtable Notes: Session 1 Table 12 WCBP 2025
Navigating 2-Tier Reference Standard Strategy for Biologics -
Moving Away from Animal Testing and Animal Derived Components Including Alternate Endotoxin Test [Session 2]
Roundtable Notes: Session 2 Table 4 WCBP 2025
Moving Away from Animal Testing and Animal Derived Components Including Alternate Endotoxin Test [Session 2] -
Moving Away from Animal Testing and Animal Derived Components Including Alternate Endotoxin Test [Session 1]
Roundtable Notes: Session 1 Table 4 WCBP 2025
Moving Away from Animal Testing and Animal Derived Components Including Alternate Endotoxin Test [Session 1] -
Microbiological Submission Roadblocks
Roundtable Notes: Session 2 Table 10 WCBP 2025
Microbiological Submission Roadblocks