Fed-batch and perfusion culture are two dominant modes of operation for mammalian-cell-culture based processes. Challenges in the industry (such as competitive products for the same indication or desired cost reductions) are forcing many to explore new production options. Increasingly popular is the application of the ATF™ System to generate ultra high viable cell concentrations (>100m cells/ml) for a “concentrated” or “intensified” process. The use of the ATF System in a typical concentrated fed-batch process is shown which has generated a protein titer of 17g/L in a CHO cell line.
Furthermore, the cost of goods and the economic feasibility is shown of manufacturing a typical glycosylated protein in a single reactor train using three production techniques – fed-batch (FB), concentrated fed-batch (CFB) and concentrated perfusion (CP). A possible major intensification of the whole upstream process is also explained as an option for a “Factory of the Future”, while the economic impact of this will be covered in a future publication.
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John Bonham-Carter, Refine Technology