ABSTRACT
Variability in nutritional requirements of commonly used production cells points to a need for culture media and supplements tailored to the specific cell line and process. The customization process can be complicated by concerns regarding the safety of the raw materials. Regulatory agency guidance on raw materials used in the production of human biotherapeutics has prompted an evolving definition of what constitutes an animalderived component. Traceability of raw materials further back in the supply chain is now a requirement and non-animal origin components may be unacceptable if a secondary manufacturing process involving animalderived material was employed. This chapter traces recent developments in sourcing of non-animal replacements. Benefits as well as potential problems associated with non-animal derived components are discussed.
