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Reference Standards: Common Practices and Challenges
Roundtable 10 Notes: WCBP 2023
Potency Assays and Use of Structure Function Models: Replacing in-vivo with in-vitro Potency Assays at Warp Speed
Roundtable 9 and 27 Notes: WCBP 2023
Developing the Right Drug Product Strength – Challenges with MaPP 5019.1 and 5019.2
Roundtable 7 and 25 Notes: WCBP 2023
Best Practices to Design Forced Degradation Studies / Design of Stability Studies for Accelerated Product Development
Roundtable 6 and 24 Notes: WCBP 2023
DA’s Requested Process Control Tables – What, Why, and How?
Roundtable 5 and 23 Notes: WCBP 2023
Comparability Strategies for Protein Based Biotherapeutics
Roundtable 4 and 22 Notes: WCBP 2023
Setting Commercial Specifications Beyond Clinical Experience
Roundtable 2 and 20 Notes: WCBP 2023
Comparability for Cell & Gene Therapy Products and Other Complex Modalities
Roundtable 1 and 19 Notes: WCBP 2023
ICH Q12 Implementation and Submission Assessment for Biotechnology Products – FDA Experience
Speaker Presentation Zhou Qing CDER, FDA 2023
FDA’s Current Effort in Structured Product Quality Submission (aka PQ/CMC)
Speaker Presentation Wu Geoffrey CDER, FDA 2023
Innovative Drug & Device Technologies & Their Impact on Quality Systems, Control Strategies & Risk Management
Speaker Presentation Wedge Rick Pfizer, Inc. 2023
Cell and Gene Therapies: FDA’s Initiatives in Accelerating Product Development
Speaker Presentation Vatsan Ramjay CBER, FDA 2023
Improved Thermal Melt Analysis Workflow with the Cary 3500 UV-VIS Spectrophotometer
Speaker Presentation Technical Seminar Presented by Agilent Technologies, Inc. 2023
WCBP 2023 Waters Technical Seminar
Speaker Presentation Technical Seminar Presented by Waters Corporation 2023
Complex Characterization Challenges and Analytical Solutions for Development of AAV Products
Speaker Presentation Technical Seminar Presented by Protagene 2023
Drug Delivery Devices A Market Perspective and Technology Discussion
Speaker Presentation Romacker Mathias Kymanox 2023
Risk Versus Benefit: Acceleration of CMC for Biologics/Vaccines Products
Speaker Presentation Risk Versus Benefit Acceleration of CMC for Biologics Vaccines Products Mini Case 2023
Platform Analytical Method Lifecycle: Trends, Strategies, and Case Study Through the Lens of mRNA Vaccines
Speaker Presentation Ripley David Pfizer, Inc. 2023
Q12 Topics and Applicability to Global Markets: Challenges for Global Expansion
Speaker Presentation Q12 Topics and Applicability to Global Markets Challenges for Global Expansion Mini Case 2023
Mass Photometry - An Innovative Biophysical Analysis Tool with Numerous Applications
Speaker Presentation Pre-Record Vendor Showcase Presented by Refeyn 2023