
Resources
Home
/
Resources
-
Host Cell Proteins – Reagent Coverage, Identification and Risk Assessment
Roundtable 9 Notes: WCBP 2020 -
Structure-Function: When, What, How and How Much?
Roundtable 8 Notes: WCBP 2020 -
Analytical Quality-by-Design (aQbD)
Roundtable 7 Notes: WCBP 2020 -
Accelerated Programs
Roundtable 6 Notes: WCBP 2020 -
Continued Process Verification: Making Data Driven Decisions
Roundtable 5 Notes: WCBP 2020 -
Cell and Gene Products - Control Strategy
Roundtable 3 Notes: WCBP 2020 -
Linking CMC and Clinical
Roundtable 1 Notes: WCBP 2020 -
Process Technology Transfer: Opportunities and Challenges
Roundtable 29 Notes: WCBP 2023 -
Successful CMC Approaches to Enable Acceleration
Roundtable 3 and 21 Notes: WCBP 2023 -
Microbial Challenge In-use Studies and Requirements
Roundtable 35 Notes: WCBP 2023 -
RNA- Vaccines and Therapeutics
Roundtable 34 Notes: WCBP 2023 -
Use of NMR Fingerprinting in Late-Stage Biologics Development
Roundtable 33 Notes: WCBP 2023 -
Reference Standards for Cell & Gene Therapy Products - Best Practices for Autologous Therapies
Roundtable 32 Notes: WCBP 2023 -
Multi-attribute Methods (MAM) Implementation Status in Biotherapeutics
Roundtable 31 Notes: WCBP 2023 -
Extractable and Leachable Studies: Best Practices to Support New Products and Process Changes
Roundtable 30 Notes: WCBP 2023 -
Quality Risk Management for Cross-Contamination in Multi-Product Facilities
Roundtable 28 Notes: WCBP 2023 -
ICH Q12- Regulatory insights, Successful Use of PACMP, Case Studies- What Worked, Didn't
Roundtable 18 Notes: WCBP 2023 -
Host Cell Proteins: Identification and Monitoring
Roundtable 16 Notes: WCBP 2023 -
Emerging Strategies on PAT, Modular Manufacturing, and Real Time Release Testing (RTRT)
Roundtable 15 Notes: WCBP 2023 -
Technical Transfer of Analytical Methods (particularly within sites and buildings)
Roundtable 11 Notes: WCBP 2023