Upcoming Webinars
Beyond USP <86>: Supplemental Testing
Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, John Duguid, Executive Director, Research & Development at Vericel Corporation, Steven Walfish, Principal Consultant at Statistical Outsourcing Services
28th April 2025
Charting the Universe of Organic Extractables
Presented by Dennis Jenke, Principal Consultant of Nelson Labs EU
12th May 2025
Optimisation of Continuous Capture Chromatography Processes
Presented by Matthias Wiendahl, Principle Scientist at Novo Nordisk A/S
15th May 2025
A Quality by Design (QbD) Approach to Microbial Retention Validation of Sterilizing Filters
Presented by Jennifer Juneau, Senior Principal Scientist at Pfizer and Annie Leahy, Senior MSAT Manager at MilliporeSigma
11th June 2025
Big Data Strategies for Cell Therapy Manufacturing
Presented by Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC
18th June 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
13th August 2025
Assessing the Use of Solid-Phase Cytometry for Rapid Bioburden Testing
Presented by Sophie Drinkwater, Associate Director in Microbiology at AstraZeneca
19th August 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
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
09th September 2025
Vaccine Development & its Manufacturing using Integrated High Throughput Technology
Presented by Dr. S.K. Jana, Director – R&D and Manufacturing, Human Vaccine Development, Serum Institute of India Pvt. Ltd.
25th September 2025
Just in Time Release of CAR T Cell Therapies
Presented by Irving Ford, VP of Quality at Adaptimmune, Owen Griffin, Senior Director, Microbiology at Rapid Micro Biosystems
03rd October 2025
Effective Extractable & Leachable Study Design
Presented by Divya Regulagedda, Manager, Global SME- Extractables & Leachables at Chemo
08th October 2025
Potency Assays and Functional Characterisation – Going Hand-in-Hand during Product Development up to Commercial Licensing
Presented by Therese Choquette, PhD. Head of Analytical and Translational Sciences at Tigen Pharma
22nd October 2025
Vaccine Development using DoE and its Manufacturing Technology with the application of Advanced Data Analytics
Presented by Dr. S.K. Jana, Director – R&D and Manufacturing, Human Vaccine Development, Serum Institute of India Pvt. Ltd.
20th November 2025
An Overview of Recent USP Bacterial Endotoxins Standards Development
Presented by Jay Bolden, Senior Director, Eli Lilly and Company Global Quality Laboratories, Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza, Director, Global Technical Services, Veronika Wills, Director, Global Technical Services at Associates of Cape Cod, Inc
04th December 2025
