The purpose of the presentation:
• Highlight some of the challenges in validating cell and gene therapy (CGT) drug substance (DS) and drug product (DP) manufacturing processes and analytical methods.
• Select challenges associated with validation of viral vector-mediated gene therapy and gene-modified cellular therapy manufacturing processes and analytical methods and offer potential solutions for them.
With an aim to:
• Bring awareness of the complexity and challenges associated with validating CGT manufacturing processes.
• Gain industry-wide consensus in addressing some of these as early as possible.
• Help drive regulatory acceptance for a clear and fast path for successful validation of the process and analytical methods.