Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date Harmonized Manufacturing Network For Sterility Assurance Frederic Ayers at Eli Lilly and Company, Martell Winters at Nelson Labs and John Schlect at Sterigenics This presentation will provide an understanding related to Global Guidance related to holistic Contamination Control Strategies. The importance of cr... 1 day ago | 142 mins Creation of a real time process data framework with external manufacturer... Olav Lyngberg, at Janssen at Teodor Leahu at IDBS Full Title: Creation of a real time process data framework with external manufacturer to enhance process performance, technology transfer success and ... February 8, 2023 3:00pm Variability, Limits, and Other Considerations for the Next Generation... Karen Zink McCullough, Kevin L Williams, Nicola Reid, Veronika Wills and Allen L. Burgenson, Full title: Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing The Limulus Amebocyte Lysate (LAL... 5 days ago | 174 mins Process Analytical Technologies – Advances in Bioprocess from Integration... Marina Kirkitadze at Sanofi and Gabriella Gerzon, and Martin Gadsby, at Optimal Industrial Technologies Ltd Full title: Process Analytical Technologies – Advances in Bioprocess from Integration to Transition to Digital Manufacturing Process Analytical Techn... 1 week ago | 137 mins Characterization of Residual Impurities in Gene Therapy Drug Products Jessica Townsend, at Intellia Therapeutics Eric S. Bishop, at Cygnus Technologies Characterization of residual impurities for gene therapy drug products is particularly challenging due to the complex nature of the final products as ... 2 weeks ago | 84 mins Enabling Robust Biomanufacturing Through Systematic Understanding of Single-Use Dr. Jun Tian, Executive Director and Head of Upstream Process Development at WuXi Biologics Full title: Enabling Robust Biomanufacturing Through Systematic Understanding of Single-Use Systems and Stringent Process and Raw Material Controls S... February 21, 2023 7:00am De-bottlenecking Challenges in Large Scale Viral Vector Manufacturing... Prateek Gupta, PhD Senior Vice President, Process Development & MSAT at Stelis Biopharma Ltd. Full Title: De-bottlenecking Challenges in Large Scale Viral Vector Manufacturing for Gene Therapy Applications The rush to develop an affordable and... March 6, 2023 3:00pm Burkholderia Cepacia Complex and Aqueous Non-Sterile Drug Manufacture... Dr John Metcalfe, Senior Pharmaceutical Quality Assessor at FDA and Dr. Doug Botkin at Charles River Laboratories Full title: Burkholderia Cepacia Complex and Aqueous Non-Sterile Drug Manufacture: Updates from a CDER Microbiologist's Perspective During this webin... April 19, 2023 2:00pm End-to-End Single-Use Manufacturing at Pilot Plant for Early Development... Agnieszka Önder , DS Operations Pilot Plant Leiden at The Janssen Pharmaceutical Companies of Johnson & Johnson Full title: End-to-End Single-Use Manufacturing at Pilot Plant for Early Development Clinical Material The Single Use Item within the Pharmaceutical ... March 14, 2023 2:00pm New-Drug Development: Succeeding With the FDA Premier Research Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the s... 3 months ago | 43 mins Load more
