News at CellGenix
GMP-quality standard of CellGro® Interleukin-4 documented with a drug master file
Freiburg, Oct. 15, 2003
As part of its strategy to produce the highest quality cytokines for use in clinical ex-vivo cell culturing in connection with cell processing kits, CellGenix has obtained a drug master file for IL-4. The active DMF, as an additional and independent proof of quality of the cytokine, simplifies the process of raw material testing for CellGenix customers.
Being part of CellGenix“Kit Systems, cytokine-cocktails play a major role in the ex-vivo processing of stem cells, dendritic cells, and gene therapy protocols. Cytokine production under cGMP regulations thereby assures highest quality and biosafety standards.
In general, the quality requirements for raw materials used for drug development in clinical studies have become more strict. Therefore it is quite difficult and expensive for investigators to identify and audit reliable suppliers who can fulfill all regulatory specifications. This requires a considerable amount of time as well as human resources for both customers and suppliers.
At this point CellGenix has chosen to undertake an extensive effort to make life easier for customers and to shorten the process of raw material testing by setting up a drug master file for human recombinant Interleukin-4.
IL-4 is produced under cGMP-conditions, expressed in E-coli and has no animal raw materials in the production or purification process. It is intended for ex-vivo use only. A batch-specific Certificate of Analysis is available.
CellGenix is now holding an active DMF which enables an investigator, upon written approval of CellGenix, to cross-reference the DMF in their own sponsored IND-application using ex-vivo processed cells in clinical research.
The master file passed without amendment. CellGenix has the ability and experience to deal not only with the most demanding technical issues, but with extensive regulatory tasks as well. This is an important point for customers planning to make future use of CellGenix“ cGMP contract manufacturing services.
Over the last 2 years we have produced more than 40 clinical batches of biologics in full compliance with cGMP requirements. We 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 on individualized and 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™.
