Development of protein-free medium for therapeutic protein production in mammalian cells: recent advances and perspectives

Mammalian cell culture media used for the manufacture of therapeutic protein have advanced systematically from serum-containing into animal-free, protein-free and chemically defined formulations over the past decades. Initially driven by patient safety concerns associated with the use of animal-derived medium components, and later by inconsistent cell culture performance due to variability in plant-derived raw material lots, many biologics manufacturers redirect their focus on the development of proprietary media formulations and implementation of well-controlled chemically defined raw materials in all cell culture media and feeds for production processes. This article will provide an overview of current trends and objectives of industrial medium development efforts for therapeutic protein production.