Clarity in cell line development

Viral Production for Gene Therapy

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 …

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Cell Line Development – A look at the evolution, new advances and future developments of this critical process step

In a recent interview with Cell Culture Dish, Dr Ian Taylor discusses the evolution of cell line development, new advances in technologies and workflows, and future advances. The discussion includes improved imaging techniques, manual limiting dilution versus single cell seeding, and achieving clonal outgrowth. Cell line development and optimization is critical to successful biomanufacturing. Could …

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Podcast | Planning a CLD Lab

Following the postponement of the BioProcess International (BPI) US West Conference, Santa Clara in March 2020,  Duncan Borthwick speaks to Mark Stockdale about the talk he was due to give, “Total Cell Line Development – A Holistic A-Z Approach for Scientists Planning A CLD Lab” Mark discusses the changes in Cell Line Development (CLD) workflows, …

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Understanding the latest FDA guidance on investigational new drugs for cell and gene therapy

On the 28th January 2020 we saw the FDA update its guidance for industry regarding chemistry, manufacturing, and control (CMC) on the application of (INDs) for cell and gene therapy, including assurance of clonality and stable cell line development. Innovation driving gene therapy Within this document the FDA provides guidance to the industry and to …

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