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
• 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 and optimisation of the upstream process
• cryoconservation of cells at each generation stage (mycoplasma tests)
• establishment of a master- and working cell bank (MCB/WCB)

Regulatory Compliance

With our comprehensive knowledge in cell biology we develop cell lines right from the start that they will be approved by regulatory authorities (FDA, BfArM, EMEA) for GMP production. Our high benchmarks during the development provide a basis for subsequent GMP production processes. We strictly comply with regulatory ICH-guidelines during the complete development phase, the selection of medium and supplements as well as cell culture consumables. We are happy to share with our customers our expertise in communicating with regulatory authorities.

Recently, we launched our successful CEMAX technology, offering a cell line generation within 4 weeks implicating the advantages of high yield expression and fully regulatory compliance.

> CEMAX Technology