The multi-purpose, single-use facility will allow for early-phase clinical manufacture of biopharmaceuticals including monoclonal antibodies and other mammalian cell culture-based recombinant proteins. CMC has partnered with Hyclone to supply the new disposable facility with processing equipment, including a 100L and two 500L single-use bioreactors (SUBs) and disposable mixers.
CMC Biologics also continues to offer its stainless-steel clinical and commercial cGMP manufacturing facility, at which the company is increasing capacity with the addition of a second 3000L bioreactor train.
"Disposable technology offers the advantages of increased flexibility and efficiency, decreased cross-contamination risks, and elimination of cleaning, sterilization and other change-over procedures typically associated with traditional steel tank facilities, while providing the same performance," said Andy Walker, senior director of manufacturing at CMC. "Consequently, it provides a cost-effective strategy for reducing the speed to market for many biologics."
Gustavo Mahler, president and chief operating officer, added, "As process yields continue to increase through advances in protein expression, cell culture, and purification technologies, the need for costly high-volume stainless steel tank facilities will decline for some products. We believe this trend will continue to push bioprocessing toward single-use technology."