By Barb Martinez, Global Senior Product Manager Custom Cell Culture Media, Courtney Walston, Supervisor, Cell Culture Media Supplier Quality, Carol Krause, Project Manager, Damon Talley, Head of Quality for Cell Culture Media
Cell culture medium is the cornerstone of a successful upstream process and foundational for long-term commercial success of a biotherapeutic. Given its central role in biomanufacturing, a consistent supply of high-quality media is required to deliver the necessary titer and protein quality while ensuring an uninterrupted process.
Because complex media formulations can include a number of components, and hundreds of options, each with its own supply chain, ensuring quality of the final media product calls for a global raw material program integrating multiple disciplines. The program should encompass a detailed understanding and characterization of the raw components used in cell culture media, in combination with well managed and defined supply networks.
In this white paper, we highlight the breadth of programs implemented across our organization to safeguard the quality of the cell culture media that are used in our customer processes – from some of the world’s highest grossing biologics to those produced on a patient-by-patient basis such as breakthrough cell therapies. Our programs represent a set of integrated disciplines focused on raw material characterization in conjunction with global supplier quality management and advanced procurement and inventory systems.