Resources

Roundtable Notes: Session 1 Table 4 WCBP 2025
Moving Away from Animal Testing and Animal Derived Components Including Alternate Endotoxin Test [Session 1]

Roundtable Notes: Session 2 Table 10 WCBP 2025
Microbiological Submission Roadblocks

Roundtable Notes: Session 1 Table 16 WCBP 2025
Molecule-Independent Device Bridging Approach (MIDBA) – a Novel Proposed Methodology for the Clinical Validation of Subcutaneous Device Platforms

Roundtable Notes: Session 2 Table 13 WCBP 2025
Method Transfer Challenges at CMOs CROs

Roundtable Notes: Session 2 Table 7 WCBP 2025
Managing/Leveraging CMOs and CTOs for Lifecycle Success  [Session 2]

Roundtable Notes: Session 2 Table 16 WCBP 2025
Host Cell Protein Assays- Are We Still Relying on Conventional Quantification by Enzyme-Linked Immunosorbent Assays (ELISAs)

Roundtable Notes: Session 1 Table 18 WCBP 2025
Global Access to Medicines in Underserved Regions

Roundtable Notes: Session 1 Table 11 WCBP 2025
Fix-Dose Co-Formulated Protein Product in Liquid or Solid

Roundtable Notes: Session 1 Table 2 WCBP 2025
CMC Challenges with Complex Formulations - Excipient Selection and Impact on Product Stability and Process Consistency

Roundtable Notes: Session 2 Table 2 WCBP 2025
CMC Challenges with Complex Formulations

Roundtable Notes: Session 1 Table 14 WCBP 2025
Applications of Artificial Intelligence - Machine Learning and Automation

Roundtable Notes: Session 2 Table 14 WCBP 2025
Allowable Excess Volume and Gross Content Requirements for Injectable Drug Products Filled in Vials or Ampules

Roundtable Notes: Session 1 Table 9 WCBP 2025
Advanced Manufacturing

Speaker Presentation: WCBP 2025
Workshop Session 3 - Hot Topic – FDA MAPP 5019.1 Allowable Excess Volume Content in Injectable Drug and Biological Products - a.k.a. deliverable volume gross content 2025

Speaker Presentation: WCBP 2025
Workshop Session 3 - Hitchhikers Guide to the Galaxy of Prior Knowledge – What Makes Sense for the More Efficient Development of Biologics 2025

Speaker Presentation: WCBP 2025
Workshop Session 3 - Bridging the Gap: Harmonizing Annex I and FDA Guidance While Understanding the Differences 2025

Speaker Presentation: WCBP 2025
Workshop Session 3 - Analytical Method Bridging Pre- and Post- Approval 2025

Speaker Presentation: WCBP 2025
Workshop Session 2 - Revolutionizing Biopharmaceuticals with AI: From Soup to Nuts 2025

Speaker Presentation: WCBP 2025
Workshop Session 2 - Patient Centric Specifications - How Can They Be Established and Maintained or if Justified Amended 2025

Speaker Presentation: WCBP 2025
Workshop Session 2 - Microbiology Topics - Sterilization Validation and Aseptic Topics in Biologics 2025