Resources
-
ICHQ6 - Challenges and Opportunities for Using an Enhanced Approach to Lifecycle Management of Specifications [Session 2]
Roundtable Notes: Session 2 Table 7 WCBP 2026
ICHQ6 - Challenges and Opportunities for Using an Enhanced Approach to Lifecycle Management of Specifications [Session 2] -
ICHQ6 - Challenges and Opportunities for Using an Enhanced Approach to Lifecycle Management of Specifications [Session 1]
Roundtable Notes: Session 1 Table 7 WCBP 2026
ICHQ6 - Challenges and Opportunities for Using an Enhanced Approach to Lifecycle Management of Specifications [Session 1] -
How to Move From Pilot Initiatives to Sustainable Programs
Roundtable Notes: Session 2 Table 10 WCBP 2026
How to Move From Pilot Initiatives to Sustainable Programs -
Host Cell Proteins and Host Cell DNA Risk Assessment for Gene Therapies
Roundtable Notes: Session 1 Table 17 WCBP 2026
Host Cell Proteins and Host Cell DNA Risk Assessment for Gene Therapies -
Host Cell Proteins (HCP) and Host Cell DNA Risk Assessment for Gene Therapies
Roundtable Notes: Session 2 Table 15 WCBP 2026
Host Cell Proteins (HCP) and Host Cell DNA Risk Assessment for Gene Therapies -
Host Cell Protein Assays- Are We Still Relying on Conventional Quantification by Enzyme-Linked Immunosorbent Assays (ELISAs)?
Roundtable Notes: Session 1 Table 13 WCBP 2026
Host Cell Protein Assays- Are We Still Relying on Conventional Quantification by Enzyme-Linked Immunosorbent Assays (ELISAs)? -
Expectations for the Development and Application of Extended Characterization Methods [Session 2]
Roundtable Notes: Session 2 Table 5 WCBP 2026
Expectations for the Development and Application of Extended Characterization Methods -
Expectations for the Development and Application of Extended Characterization Methods [Session 1]
Roundtable Notes: Session 1 Table 5 WCBP 2026
Expectations for the Development and Application of Extended Characterization Methods -
Challenges When Working with Contract Development Manufacturing Organizations (CDMOs)
Roundtable Notes: Session 2 Table 16 WCBP 2026
Challenges When Working with Contract Development Manufacturing Organizations (CDMOs) -
Challenges and Best Practices for Global Implementation of Analytical Procedures –Use of the Analytical Target Profile as Described in ICH Q14
Roundtable Notes: Session 1 Table 14 WCBP 2026
Challenges and Best Practices for Global Implementation of Analytical Procedures –Use of the Analytical Target Profile as Described in ICH Q14 -
Best Practices in Peptide Map/MS/MS Analysis of Degradation Products and Disulfide Linkage Analysis
Roundtable Notes: Session 1 Table 10 WCBP 2026
Best Practices in Peptide Map/MS/MS Analysis of Degradation Products and Disulfide Linkage Analysis -
WCBP 2026 Scientific Program
Scientific Program: WCBP 2026
-
Regulatory Considerations for Multispecific Antibody-Based Products for BLA and Beyond
Speaker Presentation: CMC Strategy Forum North America 2026
Swisher Jennifer, CDER. FDA, 2026 -
Ensuring Drug Product Content Meets Label Claim -- Are You Getting What You Paid For?
Speaker Presentation: CMC Strategy Forum North America 2026
Rivera Rosado Leslie, CDER, FDA, 2026 -
Late-Stage CMC Analytical Speed Bumps: When ‘Later’ is Suddenly Now…
Speaker Presentation: CMC Strategy Forum North America 2026
Ritter Nadine, Global Biotech Experts, LLC, 2026 -
Regulatory Considerations for Early-Stage Development of Bi-, Tri-, and Multi-Specific Therapeutics
Speaker Presentation: CMC Strategy Forum North America 2026
Parmar Hiren, Health Canada, 2026 -
Control Strategies Tailored for Multispecifics
Speaker Presentation: CMC Strategy Forum North America 2026
Ni Wenqin, Pfizer, Inc., 2026 -
Compendial Expectations for Dose Content and Uniformity for Biologics
Speaker Presentation: CMC Strategy Forum North America 2026
McCarthy Diane, US Pharmacopeia, 2026 -
Strategies for Successful Development and Manufacturing of Multi-Specific Antibodies and Proteins
Speaker Presentation: CMC Strategy Forum North America 2026
Chang Yuan, WuXi Biologics, 2026 -
Strategies for Analytical Characterization of Multi-Specific Proteins
Speaker Presentation: CMC Strategy Forum North America 2026
Auclair Jared, Northeastern University, 2026