Batavia Bioservices offers two types of cell line generation program, both of which are built around serum-free adapted CHO cells, either the commercially available CHO-S cell line or our proprietary CHO-K1 cell line and reagents and media that are fully animal component free.
The core of the cell line generation capabilities at Batavia bioservices aims to generate and select a stable CHO cell line that expresses the product of interest at high level in a commercially available, serum-free medium and that is of pharmaceutical grade (ie; suitable to produce material for clinical studies).
Following transfection, cell lines are selected and expanded under antibiotic selection in serum-free culture conditions. Final selection takes place in small scale batch or fed-batch cultures in shake flask or shaken square bottles, which offer scalable and reliable performance up to 20L and above in bioreactors.
The selected cell lines are cryopreserved in ampules and supplied to the customer together with a QA approved report and all associated documentation outlining the history of the cell lines such that the generated cell lines are suitable for clinical studies. This basic process takes approximately 18 weeks from DNA to the selection of the final (non-clonal) cell lines.
Production of material from these stable cell lines for characterization and analysis at 1L-20L scale can be performed, which means that first material can be obtained approximately 26 weeks after transfection.
Additional optional packages we offer include the assessment of cell line stability, where selected cell lines are cultured over multiple passages with productivity and cell culture performance being assessed at regular intervals, and a sub-cloning step in which delivery of a final clonal cell line is guaranteed. Each of these processes takes approximately 12 weeks.
As a way to combine the generation of stable cell lines with a more rapid and cost effectively delivery of high quality material for proof-of-concept and early pre-clinical studies, we offer a service to generate stable CHO cell pools.
Following transfection, high producing cell pools can be generated and selected in serum free batch cultures in the same way as the stable cell lines, with the exception that the pools can be available within 10 weeks. The selected pools can then be used to generate mg or gram quantities of material in generic batch or fed-batch processes such that this material is available for proof-of-concept or early pre-clinical studies within 16 weeks following transfection, at least 8 weeks earlier and at reduced cost compared to using stable cell lines.
The cell pools are generated according to the same stringent standards and documentation as the stable cell lines and the selected pools are cyryopreserved for future use. This means that if there is a decision to proceed with product development with one or more of the selected cell pools these can be cultured under limiting dilution conditions such that stable cell lines are obtained that are then suitable for clinical productions.