News at CellGenix
CellGenix registers FDA Drug Master Files for CellGro® TNF-alpha and GM-CSF
Freiburg, June 05, 2005
CellGenix has registered two new drug master files for TNF-alpha 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.
S. Brunswieck, PhD, Head of CellGenix Marketing & Sales department, emphasizes the importance of this late achievement: "the new USP 1043 is an anchor point for quality politics of ancillary materials. I am very happy that CellGenix“ ex-vivo grade cytokines provide full compliance with these new and important regulations."
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-alpha 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.
Over the last years CellGenix has produced more than 50 clinical batches of biologics in full compliance with cGMP requirements. We also offer this extensive know-how for the production of recombinant proteins, in a state-of-the-art facility for full-scale cGMP-compliant manufacturing (molecular biology, cell banking and storage, microbial fermentation development, cell culture development, downstream processing, analytical and quality control services, quality assurance, regulatory affairs and project management).
CellGenix is a well-established, product-oriented biotech company focused tailor-made cell and protein therapeutics for cancer treatment and orthopedic surgery. In addition, the company provides high-quality reagents and culture medium for ex-vivo therapeutic cell processing. We are constantly improving the quality of our products and services in order to further economize the time-to-market for our customers.
CellGro® is a registered trade mark of CellGenix in several European countries and Japan.
In the U.S.A. and Canada CellGro® products are distributed under the name of CellGenix™.
