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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

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How to Reduce the Vein to Vein Timeframe Through Efficient, Accelerated QC & Release Testing

Cell Therapy Quality/ CMC & Analytics

Adrian P Gee

An issue associated with certain types of cellular therapies is the ability to manufacture and test the cell product within the timeframe available to treat the patients. Some products, such as extensively expanded cells, require prolonged manufacturing and manipulation ex vivo, with the result that the intended recipient’s disease may have progressed by the time the product is available, and they are no longer eligible for the treatment. To a lesser extent, the time required to release test the product can cause delays to administration and may require use of two-stage testing, with provisions to deal with failing results obtained after the product has been administered. This article discusses strategies that can be used to reduce manufacturing and release testing delays using state of the art techniques that can accelerate product availability. It focuses on products being used under Investigational New Drug (USA)/Investigational Medicinal Product (EU) approvals.

DOI: 10.18609/cgti.2019.006
Submitted for review: November 20, 2018
Citation: Cell & Gene Therapy Insights 2019; 5(1), 43–50.
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