On Demand Webinars

CCAB: Addressing the risk of microbial impurities in Biologics and certain Advanced Therapy Medicinal Products (ATMPs)

Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST (individual Neoepitope Specific Therapy), Roche and Nahuel Paolini, PhD, Sanquin Reagents
28th March 2022


CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy

Presented by Sarah Thomas, Vice President of Quality at REGENXBIO Inc. and Joanna Zmurko, NGS specialist at PathoQuest
23rd March 2022


An impurity detected in a stability study: Did we miss anything in our E&L risk assessment?

Presented by Petra Booij, Investigator bij GlaxoSmithKline and Ward D’Autry, PhD Study Director at Nelson Labs Europe
15th March 2022


Holistic Approach to the Industry 4.0 Investment Breaking Down the Fences Between R&D & Manufacturing

Presented by Christos Varsakelis, Team Lead Artificial Intelligence/Machine Learning at The Janssen Pharmaceutical Companies of Johnson & Johnson and Shilpa Nargund, Director at Insilico Biotechnology Pte. Ltd., Singapore
14th March 2022


Regulatory Strategies For Rapid Sterility Testing of Gene and Cell Therapy Products

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
07th March 2022


Overcoming Antibody-Drug Conjugate (ADC) Process Development & Manufacturing Challenges

Presented by Dr. Jimmy Li, CEO of WuXi XDC (a WuXi Biologics subsidiary)
23rd February 2022


In-line monitoring of surfactant clearance in viral vaccine downstream processing

Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur
15th February 2022


We Are Going Back to the Future with Rapid Methods.

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Félix Montero-Julian, Scientific Director at bioMérieux
14th February 2022


Handling mutagenic extractable and leachable compounds released from devices

Presented by Ron Brown, Toxicologist at Risk Science Consortium and Piet Christieans, PhD, Scientific Director at Nelson Labs
10th February 2022


Applications of industry 4.0 concepts in continuous pharmaceutical tablet manufacturing process

Presented by Dr Ravendra Singh, Research Faculty at C-SOPS, Department of Chemical and Biochemical Engineering, Rutgers University, NJ, USA
27th January 2022