Papers and Presentations
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Managing/Leveraging CMOs and CTOs for Lifecycle Success [Session 1]
Roundtable Notes: Session 1 Table 7 WCBP 2025Managing/Leveraging CMOs and CTOs for Lifecycle Success … -
Wide-Spread Adoption of High-Volume Delivery Subcutaneously - What’s the Hold-Up
Roundtable Notes: Session 1 Table 15 WCBP 2025Wide-Spread Adoption of High-Volume Delivery Subcutaneously … -
What Are the New Alternate Lipids for Lipid Nanoparticles
Roundtable Notes: Session 1 Table 17 WCBP 2025What Are the New Alternate Lipids for Lipid … -
Vaccine Manufacturing New Technologies for mRNA Production
Roundtable Notes: Session 2 Table 15 WCBP 2025Vaccine Manufacturing New Technologies for mRNA … -
The Road to One Global CMC Dossier [Session 1]
Roundtable Notes: Session 1 Table 5 WCBP 2025The Road to One Global CMC Dossier [Session 1] -
The Road to One Global CMC Dossier [Session 2]
Roundtable Notes: Session 2 Table 5 WCBP 2025The Road to One Global CMC Dossier [Session 2] -
Tech Transfer Challenges and How to Avoid Common Mistakes
Roundtable Notes: Session 2 Table 17 WCBP 2025Tech Transfer Challenges and How to Avoid Common … -
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 2025Setting Specifications on Limited Data, Clinically Relevant … -
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 2025Setting Specification (Including Potency) for Not Well-Characterized … -
Relevance of Accelerated and Forced Degradation Studies for a Frozen DS DP [Session 1]
Roundtable Notes: Session 1 Table 6 WCBP 2025Relevance of Accelerated and Forced Degradation Studies … -
Relevance of Accelerated and Forced Degradation Studies for a Frozen DS DP [Session 2]
Roundtable Notes: Session 2 Table 6 WCBP 2025Relevance of Accelerated and Forced Degradation Studies … -
Recent Trends in Questions from Global Health Authorities [Session 1]
Roundtable Notes: Session 1 Table 3 WCBP 2025Recent Trends in Questions from Global Health Authorities … -
Recent Trends in Questions from Global Health Authorities [Session 2]
Roundtable Notes: Session 2 Table 3 WCBP 2025Recent Trends in Questions from Global Health Authorities … -
Practical Applications of AI and ML in Discovery, Development and Platform Establishment Including CQA Controls
Roundtable Notes: Session 1 Table 13 WCBP 2025Practical Applications of AI and ML in Discovery, Development … -
Navigating 2-Tier Reference Standard Strategy for Biologics
Roundtable Notes: Session 1 Table 12 WCBP 2025Navigating 2-Tier Reference Standard Strategy for … -
Moving Away from Animal Testing and Animal Derived Components Including Alternate Endotoxin Test [Session 2]
Roundtable Notes: Session 2 Table 4 WCBP 2025Moving Away from Animal Testing and Animal Derived Components … -
Moving Away from Animal Testing and Animal Derived Components Including Alternate Endotoxin Test [Session 1]
Roundtable Notes: Session 1 Table 4 WCBP 2025Moving Away from Animal Testing and Animal Derived Components … -
Microbiological Submission Roadblocks
Roundtable Notes: Session 2 Table 10 WCBP 2025Microbiological Submission Roadblocks -
Molecule-Independent Device Bridging Approach (MIDBA) – a Novel Proposed Methodology for the Clinical Validation of Subcutaneous Device Platforms
Roundtable Notes: Session 1 Table 16 WCBP 2025Molecule-Independent Device Bridging Approach (MIDBA) … -
Method Transfer Challenges at CMOs CROs
Roundtable Notes: Session 2 Table 13 WCBP 2025Method Transfer Challenges at CMOs CROs