Recombinant monoclonal antibodies and other therapeutic proteins are largely produced using Chinese hamster ovary (CHO) cells. After selection of a high producing clone, choice of the growth medium for cell culture and production in bioreactors becomes critical. The chemical composition of the cell culture medium plays important roles in the growth and sustenance of cells in the bioreactor and influences the expression of recombinant proteins and protection of critical quality attributes for the efficacy of the therapeutic protein. The recent global supply chain disruptions caused by COVID 19 pandemic revealed a vulnerability in maintaining un-interrupted production of quality protein drugs, especially in the supply of cultural medium or the raw materials used in the preparation of the cultural medium. Specifically, the supply chain disruptions affected the supply of the cell culture medium that we optimized for a production process of an IgG1-κ mAb (VRC01) from a CHO-K1 cell line. This is a highly glycosylated mAb and is known to broadly neutralize several strains of Human Immunodeficiency Virus (HIV). In our quest to identify an alternate medium, we investigated the extent of effect of 3 different commercially available media on the production and glycosylation of this mAb. All these 3 media are manufactured free of animal origin substances. The findings of this study can be useful for protein drug product developers who are in the early development stages to build sufficient redundancy for a successful product launch and to overcome unforeseen setbacks to the production medium.

Monoclonal antibody production and glycosylation of a CHO cell line in three commercial media

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