When cell lines are used to produce a biological product, a cell bank system should be used. Particularly in case that your protein of interest will follow clinical studies, regulatory agencies require cell bank manufacturers to guarantee continued stability and safety of cell lines producing biologics under cGMP.

The model of cell banking is applicable to any microbial or mammalian cell line. However, each host or cell bank and to produce each product and with for each intended purpose will require different cell banking generation and characterization activities.

Regulatory agencies will finally determine which tests must be performed based on the production host and the specific product, but typically always including identity, stability and purity.

53Biologics has generated and characterized more than 100 cell banks for our clients (many more not requiring cGMP compliance) that will be used for the manufacture of therapeutics biologics. Even being microbial (E. coli, Pichia or even more rare platforms) or mammalian, our cell banking team is able to generate the required number of vials in our cGMP-compliant clean rooms.

Our solid Quality systems and standards assures that all the vials of each master cell bank are generated and preserved assuring the enough supply of this material for the life of the product.  The standard release criteria of viability and sterility is provided with a full characterization services for further regulatory-based testing of our client’s cell bank.

Once the research cell bank is generated at 53Biologics or arrives from our clients, 53Biologics specialists will first carry out the prebank testing, generate the batch, release and characterize it gathering and maintaining all the generated vials, information, batch records and results for our clients.

53Biologics offers directly or through partners a strong catalogue analytical services including molecular, genetic and microbial assays for the characterization of the generated Master Cell Banks (MCB), Working Cell Banks (WCB) and End of Production Cells (EOPC) like:

  • Identity testing, i.e. 16S rRNA Sequencing, Plasmid or Expression Construct Sequencing, Restriction Fragment Analysis

  • Stability determination, i.e. Marker Retention Testing, Copy Number Analysis by qPCR

  • Purity determination, i.e. API 20 Test, Gram Staining, Bacterial & Fungal Impurity, E. coli Strain Identity