Upcoming Webinars
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 a Representative Review Case
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, and Quynh Ton, Ph.D, Regional Sales Director: NGS Application Specialist at Pathoquest
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, Atanu Sengupta, Lead – New Technologies & External Collaborations at Dr. Reddy’s Laboratories, 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, Mateusz Imiolek, Principal Scientist at Waters
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, Microbiology Expert/Senior Technical Steward Manufacturing Science and Technology at Novartis Pharma AG, Dr. Friedrich von Wintzingerode, Director, ADQC Microbiological Sciences at Roche-Genentech, Dr. Lori Daane, Founder and Principal Scientist at Macro Scope BioConsulting, Dr. Ambili Menon, Senior Scientific Affairs Manager at bioMérieux
11th November 2026
Sterilization and Packaging Development: The Chicken and Egg Dilemma
Presented by Logan Luke, Senior Expert Consultant, Nelson Labs And Jean-Francois (Jeff) Zeevaert, Principal Scientist Gas Sterilization, Sterigenics
17th November 2026
Pharma Industry 4.0 Will be Advanced by the Data Enablement of People
Presented by Malcom Jeffers, Transformation Strategist, Head of Research at the International Academy of Automation Engineering, Alan Bateman, Director: Systems Architecture, Digital, and Execution at Johnson & Johnson Innovative Medicines, Dan Hill, Director, Process Analytics at Fujufilm Biotechnologies
18th November 2026
Characterization of Lipid Nanoparticles Using Macro Mass Photometry Insights into Size & Mass
Presented by Presented by Jikang Wu, Senior Principal Scientist in Analytical and Biological Mass Spectrometry at Regeneron Pharmaceuticals
19th November 2026
Aggregation Analysis in AAV: Selecting Fit-for-Purpose Assays
Presented by Margaret Butko, Ph.D., Senior Advisor of CMC Assay Development at Eli Lilly and Company, Rickard Nordström Chief Operating Officer at QuTEM
02nd December 2026
Integrating E&L Assessment and Filter Validation for Sterilizing Grade Filters used in (Bio-)Pharmaceutical Manufacturing
Presented by Presented by Lijun Song, PhD, Scientific Project Manager at Nelson Labs and Peter Cornelis, Senior expert Microbiology and Sterilization at Nelson Labs
10th December 2026
Applied Automation and Mechanistic Modeling for Purification Development of Challenging Molecules under Accelerated Timelines
Presented by Scott H. Altern, Senior Scientist II at AbbVie Bioresearch Center in Worcester, MA
11th January 2027
Navigating Assay Re-Development & Transfer to Reduce Risk & Delays in GMP Testing
Presented by Sviatlana Rose, Principal Scientist at Sanofi
15th January 2027
Scaling Up TFF for Upstream Continuous Processing: Applications of Mechanistic Modeling
Presented by Ashna Dhingra, Bioprocess Technologies & Engineering, Senior Scientist, AstraZeneca
28th January 2027
Process Development to GMP Implementation of Raman Spectroscopy as a PAT Tool for the Purification of Protein Based Therapeutics
Presented by Christina Passno, Senior Staff Engineer, Preclinical Manufacturing & Process Development at Regeneron Pharmaceuticals
02nd February 2027
Accelerating Biologics Development Through Advanced Analytics and Digital Transformation
Presented by Christian Airiau, PhD, Global Head Data Sciences, CMC at Sanofi
03rd February 2027
