BioPhorum IT: Lab of the Future – Manifesto: digital technology-based capabilities for the quality control lab of the future

Broadcast date

Thu, Feb 17, 2022


Presented by

    Graeme Carter - Pfizer


Quick Description


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.


Graeme Carter

Senior Manager, Lab of the future