Biotherapeutic protein production is driven by cell line, cell culture media and supplementation, and bioprocess. While improvements in cell culture media and supplementation have enabled significant advancements in bioproduction titers, optimization to meet the specific needs of individual production cell lines continues to be a key factor to achieving desired production and protein quality. This is especially relevant to the ever increasing number of biosimilar therapeutics. Not only is it desirable to achieve a cost effective level of production, it is essential that quality characteristics, such as glycosylation and charge variant profiles, are correct and, in the case of biosimilars, closely resemble those of originator molecules.
While fully chemically defined (CD) media formulations are desirable due to the presumed higher levels of raw material consistency and reduced risk from the omission of animal origin or chemically undefined materials, CD formulations may or may not meet production or quality requirements. Depending upon the nutritional and culture requirements of the bioproduction cell line and process, both CD supplements and protein hydrolysates have been shown to provide necessary supplementation to achieve desired production and protein quality.
During this Ask the Expert, James Brooks, PhD, R&D Manager, will illustrate how BD has successfully used both CD supplements and protein hydrolysates to address production and protein quality.