Celonic launches stand-alone GMP analytics portfolio
Challenging positions in upstream processing
Cell Line Development
In order to develop cell lines that comply with regulatory guidelines, Celonic uses adherent or suspension cells (e.g. CHO-K1, CHO-DHFR-, NS0-, NS1-Hybridoma) and human (HEK293) host cell lines which meet the specifications of the FDA or EMeA respectively. The generation of cell lines includes the following stages:
- stable transfection of host cells with different expression systems suitable for the production process
» a significant time saving effect can be achieved by using Celonic’s license free technology of transfection in serum free or chemically defined media
- selection of single clones with high productivity (cloning, subcloning)
- substantial analytics of the cells and the expressed product during the selection process (growth assays, quantification of expression, glycosylation status, Western blot, stability assays extending over several generations including karyotype and FACS analysis)
- selection of suitable clones for the adaptation to serum- or protein-free medium (if necessary) and optimisation of the upstream process
- cryo-conservation of cells at each generation stage (mycoplasma tests)
- establishment of a master- and working cell bank (MCB/WCB)
With our comprehensive knowledge in cell biology we develop cell lines right from the start that they have been and will be approved by regulatory authorities (FDA, BfArM, EMeA) for GMP production. Our high benchmarks during standard development programs and add-on development services provide a basis for achieving stable and effective GMP production processes. We strictly comply with regulatory ICH-guidelines during the complete development phase. We are happy to share with our customers our expertise in communicating with regulatory authorities.
With our CEMAX technology we offer a "fast-track" cell line generation within 4 weeks implicating the advantages of high stability in scale-up, yield expression and full regulatory compliance.
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