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CellGenix registers FDA Drug Master Files for ex-vivo CellGroŽ TNF-a and GM-CSF

16 Jun 2005 - CellGenix has registered two new drug master files for TNF-a and GM-CSF. After filing a DMF for IL-4, this contributes further to the strategy of producing highest quality cytokines for the use in clinical ex-vivo cell culturing in connection with cell processing kits. As proposed in the new USP chapter 1043, which became effective on April 1, a DMF cross reference is recommended for all ancillary materials used in clinical cell therapy.
 
Together with further quality and safety features, like animal-derived-free raw materials or batch-specific certificates-of-analysis, CellGenix´ ex-vivo grade cytokines fulfil all major recommendations given in USP 1043.
 
The cytokines are produced under cGMP-conditions, expressed in E-coli and no animal derived raw materials are used in the production or purification process. TNF-a and GM-CSF are intended for ex-vivo use only. Batch-specific Certificates of Analysis are issued and sent with each delivery.
 
CellGenix has filed these two DMFs which enable an investigator, upon written approval of CellGenix, to cross-reference either DMF in their own sponsored IND-application using ex-vivo processed cells in clinical research.