Upcoming Webinars

Process Analytical Technologies – Advances in Bioprocess From Integration to Transition to Digital Manufacturing

Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur and Gabriella Gerzon, PhD Candidate, York University, Toronto, Canada, and Martin Gadsby, Vice President , Optimal Industrial Technologies Ltd
31st January 2023

Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Kevin L. Williams, Microbiological Test Development at bioMérieux, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, Veronika Wills, Manager, Technical Services at Associates of Cape Cod, Inc and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions Lonza Walkersville, USA
02nd February 2023

Harmonized Manufacturing Network For Sterility Assurance

Presented by Frederic Ayers, Advisor, Global Quality Systems at Eli Lilly and Company, Martell Winters, Director of Scientific Competence at Nelson Labs and John Schlecht, Vice President Technical Services, Sterigenics
06th February 2023

Creation of a Real Time Process Data Framework With External Manufacturer to Enhance Process Performance, Technology Transfer Success and Drive Cost Savings

Presented by Olav Lyngberg, Advanced Analytics, Modeling & Process Analytical Technology Leader at The Janssen Pharmaceutical Companies of Johnson & Johnson and Teodor Leahu, Director of European Operations at IDBS
08th February 2023

Demonstrating Analytical Comparability in Analytical Development

Presented by Santoshkumar Khatwani, Director Analytical Development at Sangamo Therapeutics and Svea Cheeseman, Director of Product Management Cell & Gene Therapy at Refeyn
14th February 2023

Orthogonal Measures of Lentiviral Particle Attributes Using DLS, NTA, and Micro Flow Cytometry

Presented by Jim Richardson, Senior Director, Analytical Development at Interius Biotherapeutics and Kevin Lance, PhD, Director of Viral Vector Marketing at Unchained Labs
16th February 2023

Enabling Robust Biomanufacturing Through Systematic Understanding of Single-Use Systems and Stringent Process and Raw Material Controls

Presented by Dr. Jun Tian, Executive Director and Head of Upstream Process Development at WuXi Biologics
21st February 2023

Chromatography Based Near-Real-Time Measurements & Timely Control of Product Titer, Product Quality and Cell Culture Nutrients

Presented by Letha Chemmalil, Scientific Associate Director at Bristol Myers Squibb, Magnus Wetterhall Global Marketing Manager - Bioprocessing at Waters Corporation and Nick Pittman Global Marketing Manager - Biopharmaceuticals at Waters Corporation
23rd February 2023

CBER’s Perspective on Evaluation and Implementation of Rapid Microbial Methods

Presented by CAPT Simleen Kaur, Team Leader for Laboratory of Microbiology In-vivo Testing and Standards at FDA Center for Biologics and Evaluation and Research, Lori Daane, Sr. Director of Scientific Affairs at bioMérieux and Jon Kallay, Senior Technical & Market Development Manager, Charles River Microbial Solutions
01st March 2023

De-bottlenecking Challenges in Large Scale Viral Vector Manufacturing for Gene Therapy Applications

Presented by Presented by Prateek Gupta, PhD Senior Vice President, Process Development & MSAT at Stelis Biopharma
06th March 2023

Lessons Learned and Benefits Gained from the Global Implementation of an Automated Endotoxin Testing Solution

Presented by Dennis Wong, Global QC Technical Lead, Global Quality Control, Operations, AstraZeneca Liverpool UK and Jordi Iglesias, Technology and Market Development Manager at Charles River
09th March 2023

End-to-End Single-Use Manufacturing at Pilot Plant for Early Development Clinical Material

Presented by Agnieszka Önder , DS Operations Pilot Plant Leiden at The Janssen Pharmaceutical Companies of Johnson & Johnson
14th March 2023

Advanced Digitalization Plan for AstraZeneca’s CDC line

Presented by Melanie Dumarey, Product and process design engineer (associate principal scientist) at AstraZeneca
15th March 2023

Platform Technology To Speed Up CMC Process

Presented by Dr H. Fai Poon, President, QuaCell Biotech Ltd
15th March 2023

Building the Lab of the Future Through AI, ML & Cultural Change

Presented by Christos Varsakelis, Team Lead Artificial Intelligence/Machine Learning at The Janssen Pharmaceutical Companies of Johnson & Johnson
23rd March 2023

Adaptation of the Analytical Control Strategy of a Commercial Vaccine Using the Principles of QbD. Challenges, Lessons Learned and Improvement Perspectives

Presented by Jean-Francois Dierick, Strategic Analytical Validation and Lifecycle Lead Analytical Research & Development (ARD) Vaccines Research & Development at GSK
30th March 2023

Points to Consider When Defining a Microbial Control Strategy for Individualized ATMPs

Presented by Friedrich von Wintzingerode, PhD, QC Lead iNeST Project at Roche
05th April 2023

Contamination Control Challenges Facing Cell Therapy Facilities

Presented by Conor McMorrow, Aseptic Lead, Cell Therapy at Takeda at Félix Montero-Julian, Scientific Director of Pharma Quality Control at bioMérieux
17th April 2023

GMP Implementation of Continuous Manufacturing: A case study

Presented by Neil Soice, Executive Director, Drug Substance Technologies at Amgen, Inc. and Michael Phillips, BioContinuum™ Platform Director, MilliporeSigma
18th April 2023

Burkholderia Cepacia Complex and Aqueous Non-Sterile Drug Manufacture: Updates from a CDER Microbiologist’s Perspective

Presented by Dr John Metcalfe, Senior Pharmaceutical Quality Assessor at FDA and Dr. Doug Botkin, Technology and Market Development Manager at Charles River Laboratories
19th April 2023

Stabilising The Biologics Supply Chain with Blockchain

Presented by Alexandru Popa, Associate Director, Blockchain for Pharma Supply Chain at MSD
20th April 2023

Challenges And Opportunities Of Continuous Bioprocessing And Risk Management

Presented by Sethu Madhavan, Global Head of Insulin Operations at Biocon Biologics
27th April 2023

Trends and Future of Pharmaceutical Continuous Manufacturing

Presented by Lawrence De Belder, Continuous Manufacturing Practice Lead at Pharmatech Associates, Inc. and Jan Vogeleer, Managing Director at Fette Compacting
27th April 2023

Technologies and Platform Approach for Optimizing Downstream Purification of Viral Vectors

Presented by Ashish Saksule, Principal Scientist, Vector Core Lead at Vertex Pharmaceuticals and Dr Alejandro Becerra, Principal Applications Scientist and Global Purification Technical Lead at Thermo Fisher Scientific
10th May 2023

Ruggedness and Robustness in Nitrosamine Analysis from Pharmaceutical Elastomers

Presented by Jason Creasey, Managing Director at Maven E&L Ltd
23rd May 2023