Cell and gene therapy validation challenges

Broadcast date

Tue, Feb 22, 2022

 

Presented by

    Sharif Ahmed - Bayer

 

Quick Description

With the purpose to highlight some of the challenges in validating cell and gene therapy (CGT) drug substance (DS) and drug product (DP) manufacturing processes and analytical methods, this webinar aims to bring an awareness of the complexity associated with these processes.

Details

With the purpose to highlight some of the challenges in validating cell and gene therapy (CGT) drug substance (DS) and drug product (DP) manufacturing processes and analytical methods, this webinar aims to bring an awareness of the complexity associated with these processes. Highlighting some of the select challenges associated with validation of viral vector-medicated gene therapy and gene-modified cellular therapy manufacturing processes and analytical methods, potential solutions are offered for them.
The aim is to gain industry-wide consensus in addressing some of these challenges as early as possible and help to drive regulatory acceptance for a clear and fast path for a successful validation of the process and analytical methods.

Speakers

Sharif Ahmed

Director, Process Validation - Global MSAT-Biotech

Bayer