Development of Fed-Batch Process Producing Monoclonal Antibodies Using In-House Media

Abstract

IDEC Pharmaceuticals has devoted efforts for maximizing monoclonal antibody (MAb) production to fulfill increasing clinical and market demand. Cell Culture Process Sciences is equipped with numerous 5L stirred-tank bioreactors that provide cultures a well-controlled environment suitable for parameter studies during early stages of process development. In-house medium development is an on-going effort to ensure the full ownership of IDEC Mabs manufacturing process. Manipulation of amino acid contents in both basal and feed media can effectively promote cell growth and control toxic by-products. A harvest titer of 1–2 g/L MAbs in a two-week fed-batch process is routinely achieved using IDEC-owned in-house medium. The resulting volumetric productivity is over 100 mg/L/day, comparable to a process using vendor's proprietary medium.