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 Considerations to Improve Patient Outcomes in Early Drug Development Premier Research | Premier Consulting Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not jus... March 30, 2023 3:00am Advanced digitalization plan for AstraZeneca's CDC line Presented by Melanie Dumarey, Product and process design engineer (associate principal scientist) at AstraZeneca Presented by Presented by Melanie Dumarey, Product and process design engineer (associate principal scientist) at AstraZeneca 6 days ago | 47 mins Adaptation of the analytical control strategy of a commercial vaccine... Jean-Francois Dierick at GSK Full Title: Adaptation of the analytical control strategy of a commercial vaccine using the principles of QbD. Challenges, lessons learned and improve... March 30, 2023 2:00pm Accelerate Product Approval Using In Silico Modeling & Simulation Premier Consulting In clinical research and development, comparison to a control is highly recommended by regulatory agencies for the purpose of demonstrating evidence o... March 30, 2023 1:00pm 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 Demonstrating Analytical Comparability in Analytical Development Santoshkumar Khatwani at Sangamo Therapeutics and James Wilkinson at Refyn The presentation will focus on challenges in analytical comparability for gene therapy products. In addition, orthogonal methods along with some of th... 1 month ago | 86 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 months 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... 4 weeks ago | 43 mins CBER's Perspective on Evaluation and Implementation of Rapid Microbial Methods CAPT Simleen Kaur, at FDA, Lori Daane at bioMérieux and Jon Kallay at Charles River Microbial Solutions Conventional microbiological methods are established and have been used for detection and identification of microbiological contamination in biologica... 3 weeks ago | 119 mins Contamination Control Challenges Facing Cell Therapy Facilities Conor McMorrow at Takeda and Félix Montero-Julian at bioMérieux The presentation aims to provide an overview of challenges that can be faced with the knowledge that a one size fits all approach cannot be taken. Whi... April 17, 2023 2:00pm Load more
