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Cesca Therapeutics subsidiary filed MAF with FDA.

Cesca Therapeutics announced that its device subsidiary, ThermoGenesis has filed a Device Master File, or MAF, with the FDA for its X-LAB automated cell processing device. The X-LAB device isolates and purifies target cell fractions from blood, bone marrow or leukapheresis in a "closed system," with precision and high efficiency. It also serves as an efficient and ficoll-free platform to isolate human T cells for chimeric antigen receptor-T cell therapeutics. This MAF contains all the relevant information that the FDA will need to allow principal investigators to include Cesca's systems in their investigational new drug applications, or INDs, while also protecting Cesca's intellectual property.

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Publication:The Fly
Date:Nov 13, 2018
Words:104
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