Upcoming Webinars

Are We There Yet? A Digital Maturity Model for Enabling Process Monitoring and Artificial Intelligence in Biologics Manufacturing

Presented by Jack Prior, Head of Process Monitoring & Data/AI Strategy at Sanofi, Masaki Yamada, Head of Product at Invert
16th September 2026

Future Path for E&L per ISO 10993‑18: A Look at Emerging Technical Specifications

Presented by Sandi Schaible, President and Founder of Bonded in Science, LLC, Kevin Rowland, M.S, Executive Vice President and General Manager at Jordi Labs
22nd September 2026

Analytical Assessment of Leachables in Biological Drug Products: FDA’s Approach to Reviewing Information and Representative Review Cases

Presented by Andrey Sarafanov, PhD., Principal Investigator at U.S. FDA, Center for Biologics Evaluation and Research, Sarah Brophy, Global Scientific Director, E&L Element Materials Technology
24th September 2026

Aseptic Manufacturing for mRNA, ADCs, and Novel Biologics

Presented by Francesco Cicirello, Senior Director, Global Quality Compliance – BioNTainer at BioNTech
29th September 2026

Leveraging Next-Generation Sequencing (NGS) for Adventitious Agent Testing: Pacira’s Quality Control Strategy and Lessons Learned

Presented by Po-Yi Ho, Associate Director / Analytical Development / Cell & Gene Therapies at Pacira Biosciences
06th October 2026

Building Characterization Assays to Support Early-Stage saRNA Development and QC Alignment

Presented by Yun-Ting Kao, Senior Scientist at Immunomic Therapeutics
07th October 2026

Overcoming Bottlenecks in PAT Deployment: Bridging the Gap Between Lab & Manufacturing

Presented by Luc Nguyen, Global Head of Process Analytical Technologies (PAT) within MSAT at Sanofi, Ramila Peiris, Global Head of Process Data Management, Machine Learning, and AI Platform MSAT at Sanofi, Maryann Cuellar, Life Science Industry Manager at Endress+Hauser Optical Analysis, Michael Sachpekidis, Global Account Director at SciY
14th October 2026

Managing Analytical Procedure Lifecycles: Resolving Longstanding Mass Spectrometry Challenges for Emerging Nitrosamine and NDSRI Impurities

Presented by Jinhui Zhang, Chemist at FDA/CDER, Andrew Teasdale, Principal Consultant at Nelson Labs
15th October 2026

PAT Evolution and Implementation: Navigating Regulatory Guidelines, and Best Practices for Tool Selection and Validation

Presented by Presented by Dr. Farshid Mohammadparast, Process Analytical Technology (PAT) and Chemometrics Principal Investigator at USP, Parag Borgaonkar, MBA, Sr. Business Development Specialist at Thermo Fisher Scientific, Sudhir Dahal, PhD., Product Marketing Manager for Research Raman Products at Thermo Fisher Scientific
16th October 2026

Assessing the Use of Solid-Phase Cytometry for Rapid Bioburden Testing

Presented by Sophie Drinkwater, Associate Director in Microbiology at AstraZeneca
22nd October 2026

Navigating Particulate Matter Analysis in Biologic Drug Products: A Critical Evaluation of Flow Imaging and Light Obscuration for Product Quality Assessment

Presented by Ashwinkumar Bhirde, PhD. FDA/CDER/OPQ, Senior Research Scientist, Louise Brogan, PhD, Marketing Director, Yokogawa Fluid Imaging Technologies and Amber Raines, Ph.D., Senior Director of Client Project Management at Coriolis Pharma, U.S.
27th October 2026

Particulate Control in Parenteral Drug Delivery Devices

Presented by Rong Guo, Senior Reviewer at CDRH/FDA, Dr. Bettine Boltres, Director Scientific Affairs, Integrated Systems at West, John Rech, Technology Manager – Particle – Analytical Services at West
30th October 2026

Intelligent Biomanufacturing Systems: From Design to Control in Industry 4.0

Presented by Irina Ramos, PhD, Senior Distinguished Scientist, CMC and Innovation Lead at J&J Innovative Medicine, Dr. Tiago Matos, Assistant Professor Tecnico, University of Lisbon
05th November 2026

Endotoxin Testing of Pharmaceutical Products using Synthetic Reagents

Presented by Poppy Cliffe, Senior Scientist in Microbiology, Global Product Development at AstraZeneca, Nicola Reid, Director, Portfolio Product Manager, Pyrogen & Endotoxin Detection, Charles River
06th November 2026

Enhancing Plasmid DNA Quality Through Robust Topology Measurement

Presented by Dr. Anthony Blaszczyk, Principal Scientist in the Global Biologics Department at U.S. Pharmacopeia
09th November 2026

Roundtable Discussion: Interpreting the New US Pharmacopoeia Guidance for Sterility & Microbial Testing in Cell Therapy

Presented by Dr. Huiping Tu, Senior Principal Scientist, Microbiology, Global Biologics United States Pharmacopeia (USP), Dr David Roesti, PhD. Microbiology Expert/Senior Technical Steward Manufacturing Science and Technology at Novartis Pharma AG, Dr. Friedrich von Wintzingerode, PhD. Director, ADQC Microbiological Sciences at Roche-Genentech
11th November 2026