Innovative and economic potential of mammalian cell culture.

Innovations for economic optimization of manufacturing processes of mammalian cell culture processes address new expression systems, optimized cell culture media and feeding systems, economy of scale, efficient harvest systems for viable cell separation, redesign of downstream processing and reduction of the overall number of quality control assays. A very efficient expression system in Chinese hamster ovary cells is the NEOSPLA expression system yielding 60-100 micrograms monoclonal antibodies per cell and day. Efficient supplements in nutrient feeding are insulin and amino acids which contribute to a high extent to the productivity of the mammalian cell culture process. Large scale manufacturing processes lower cost of goods by reduction of turn around cost for cleaning and steaming in place, media preparation, number of batches for annual campaign, in-process and quality control. In downstream processing the number of process steps and the step yield are responsible for the economics. Process control systems in a computer assisted manufacturing plant increase success rate, reduces man power and minimizes shifts. In the innovative process also alternative technologies such as transgenic animals should be considered to improve the economy of the manufacturing processes.