A Rapid and Simplex Methodology for Development of Platform Bioprocess Technology for Manufacturing of Recombinant Therapeutic Proteins in Serum Free Medium at Small Scale

摘要

One of the key dynamics in development of mammalian cell culture process development is the identification, selection and optimization of a suitable cell culture production medium. There are several basal serum free medium available commercially in the market, which are still not meeting the demand of particular mammalian cell line with respect to maximum cell density, maximum productivity and quality of recombinant monoclonal antibodies. In order to necessitate these needs, a rapid and simplex methodology was developed for development of bioprocess technology for GMP manufacturing of recombinant monoclonal antibodies at shale flask level.