Upcoming Webinars
Deciphering Empty-Full Characterization: A Comparative Analysis of Available Analytical Methods
Presented by Binod Pandey, Senior Scientist at Novartis
03rd February 2025
The Critical Role of Conversion Factor in Quantitative Determination of Host Cell DNA with dPCR
Presented by Haiqing Yu, Senior Scientist, Analytical Development Department at Sanofi.
04th February 2025
Enhancing Sustainability in Biopharmaceutical Drug Development and Manufacturing
Presented by Presented by Manish Sharma, Director and Head, DS and DP Process Development at OneSource Specialty Pharma Ltd, Nandakumar Sundaramoorthy Ph.D, Director, Process Development at OneSource Specialty Pharma Ltd and joining as a panellist Prateek Gupta, PhD Senior Vice President, Process Development & MSAT at Stelis Biopharma
11th February 2025
Case Study: A Risk-Based Approach to Material Transfer Validation
Presented by Presented by Liz Brockson, Aseptic Processing and Sterility Assurance Lead in Global Sterility Assurance and Microbiology at Takeda
19th February 2025
Navigating the Complexities of mRNA Therapies Analysis: Challenges, Techniques, and Quality Assessment Strategies
Presented by Sarita Kattel, M.S, Principal Scientist, Global Biologics at USP, Khaled Yamout, CEO at Yamout Chem Consulting, LLC, Martin Gilar, Ph.D., Scientific Fellow, Seperations R&D group at Water Corporation, Roxanna Eggleston-Rangel, Applications Scientist at Phenomenex
27th February 2025
Big Data Strategies for Cell Therapy Manufacturing
Presented by Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC
05th March 2025
Using Risk Management to Design Aseptic Process Simulations
Presented by Presented by Alberto Gonzalez, Global Sterility Assurance and Microbiology Associate Director at Takeda
11th March 2025
Microbial Impact Assessment of In-Process Bioburden Limit Excursions
Presented by Friedrich von Wintzingerode, PhD. Director, Microbiology and QC individualized and cell therapy at Genentech, Cheryl Essex, MS. Head of Contamination Control, R&D Global Quality at Sanofi
20th March 2025
Grouping Extractable and Leachable (E&L) Compounds with a Common Mechanism of Action for Toxicological Risk Assessment
Presented by Ron Brown, Toxicologist at Risk Science Consortium
25th March 2025
CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy
Presented by Sarah Thomas, Senior Vice President of Quality at REGENXBIO Inc.
27th March 2025
Design of a Global Risk-Based Personnel Monitoring Assessment for a Multi-Production Operation Company
Presented by Luyen Nguyen Global Sterility Assurance and Microbiology Lead at Takeda, Hilary Chan Global Sterility Assurance and Microbiology Lead at Takeda
10th April 2025
Read Across Assessment for Potential Leachables Without Toxicological Data
Presented by Yana Chervona, Drug Safety Team Lead in Drug Safety Research and Development at Pfizer
29th April 2025
Analytical Assessment of Leachables in Biological Drug Products: FDA Approach in Reviewing Information
Presented by Andrey Sarafanov; PhD., Principal Investigator at U.S. FDA, Center for Biologics Evaluation and Research, Sandi Schaible, Executive Director, Analytical Chemistry and Regulatory Toxicology at WuXi AppTec, James Hathcock, Sr. Director, Regulatory and Validation Strategy at Cytiva
04th September 2025