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 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... February 2, 2023 3:00pm 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... 18 hours 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 ... 6 days ago | 84 mins Demonstrating Analytical Comparability in Analytical Development Santoshkumar Khatwani at Sangamo Therapeutics and Svea Cheeseman at Refyn The presentation will focus on challenges in analytical comparability for gene therapy products. In addition, orthogonal methods along with some of th... February 14, 2023 6:00pm 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 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... February 6, 2023 3:00pm Improving Preclinical Study Accuracy Using PDX with Next-Gen Multiomic Datasets Stefano Cairo, PhD, Senior Global Scientific Director, Champions Oncology With an estimated 90% of oncology drugs failing clinical trials, there is a critical need for a more robust approach to preclinical and translational ... 7 days ago | 70 mins 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... 2 months ago | 43 mins Regulatory Considerations for Working with the FDA vs. the EMA Premier Consulting This webinar will compare approval processes, types (and costs) of agency meetings, expedited programs, pediatric plans, and more. We will discuss: –... February 28, 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 Load more
