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