The BioInsights Podcast

Fit for function: developing potency assays reflective of the in vivo environment

May 10, 2024 BioInsights
Fit for function: developing potency assays reflective of the in vivo environment
The BioInsights Podcast
More Info
The BioInsights Podcast
Fit for function: developing potency assays reflective of the in vivo environment
May 10, 2024
BioInsights

Translating the therapeutic promise of cell and gene therapies into clinical reality relies on robust potency assays. However, designing assays that accurately reflect the complex mechanisms of these therapies can feel like chasing a moving target. Here, Charlotte Barker, Editor, Cell & Gene Therapy Insights, speaks with Giorgio Zenere, CMC technical project lead in the Global QC Technology Innovation Team, Kite Pharma, and Dirk Windgassen, Director of Analytical Development, Miltenyi Biotec, to discuss best practices and future trends in developing potency assays for cell and gene therapies.

Show Notes Chapter Markers

Translating the therapeutic promise of cell and gene therapies into clinical reality relies on robust potency assays. However, designing assays that accurately reflect the complex mechanisms of these therapies can feel like chasing a moving target. Here, Charlotte Barker, Editor, Cell & Gene Therapy Insights, speaks with Giorgio Zenere, CMC technical project lead in the Global QC Technology Innovation Team, Kite Pharma, and Dirk Windgassen, Director of Analytical Development, Miltenyi Biotec, to discuss best practices and future trends in developing potency assays for cell and gene therapies.

Can you each start by introducing yourselves and telling us about what you are working on right now?
What are the greatest challenges in developing potency assays for cell and gene therapies?
What is the latest regulatory guidance on potency assays for cell and gene therapy, and are there any areas of disharmony?
How can assay development be streamlined, while maintaining cost-effectiveness and safety?
What strategies can we use to address the variability inherent to cell and gene therapies?
What technological advances do you see coming down the line for CGT assay development?
What best practices would you recommend to cell and gene therapy developers in potency assay development?