Clarity in cell line development

Podcast | Viral Production for Gene Therapy

Moving towards clinical grade production

In the latest edition of this Podcast series, Duncan Borthwick speaks to Mark Stockdale about the developing regulatory landscape around viral production for clinical gene therapy.

Topics include transient and stable expression, HEK293 cells and the choice of the appropriate cells, moving from research to clinical environments and an optimistic quote from Nobel laureate Michael Levitt

Further reading

Mark Stockdale’s Blog on the latest FDA guidance on investigational new drugs for cell and gene therapy

FDA’s, “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)” Jan 2020

Mark Stockdale is a keen technology pathfinder working to amalgamate the technical and business functions. Mark worked as a Group Leader in Horizon Discovery Ltd, a scientist within Lonza Biologics, Cyclacel Ltd and started his career at Pfizer.

Duncan Borthwick is the Global Marketing Manager at Solentim. With a PhD from Edinburgh University, he has 20 years of biotech business experience.

For further information please contact [email protected]

This Podcast was recorded in the UK on 22th March 2020 and is 17 minutes long.

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