Current practices and considerations of cell and gene therapy method validation controls

Download the presentation for free 👉 bit.ly/44ROQTX The webinar focus is on identifying appropriate analytical controls to use in cell and gene therapy when dealing with both limited regulatory guidance and limited materials. ​ Starting with a short introduction to the recently published work of the BioPhorum Advanced Therapy Medicinal Products workstream, Method Validation Controls, this deliverable proposes ideal analytical controls for analytical method validation in cell and gene therapy and what alternative controls can be used when materials are scarce. Our speakers 🗣️ Parul Sharma, ‪@AstellasPharmaGlobal‬ Brian Mosley,‪@BridgeBiotherapeuticsInc‬ Yan Zhi, CSL Behring ‪@CSLBehringUS‬ Shewit Tekeste,‪@JNJInnovativeMedicine‬ Andrea Sobjak, ‪@JNJInnovativeMedicine‬ Chapters: 0:00 Webinar and BioPhorum introduction 10:19 Executive summary 11:27 Mapping the regulatory landscape 14:25 Example tables 22:44 Bridging and comparability 26:57 Panel discussion #BioPhorum #AdvancedTherapyMedicinalProducts #AdvancedTherapy #advancedtherapies #ATMP #CGT #CellTherapy #GeneTherapy #MethodValidationControls #MethodValidation