CMC Biologics, a contract manufacturing organization with manufacturing sites in Europe and the USA, today announced the completion of a new state-of-the-art disposable manufacturing facility at its Seattle, WA site. The addition comes as part of a staged major expansion plan, which will add significant production capacity to its existing facility to accommodate a growing demand for cGMP manufacture of biopharmaceuticals.
The multi-purpose, single-use facility will allow for early-phase clinical manufacture of a range of biopharmaceuticals, including monoclonal antibodies and other mammalian cell culture-based recombinant proteins. CMC Biologics 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. “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. “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.”
For other products where use of disposables is not feasible, CMC Biologics continues to offer its stainless-steel clinical and commercial cGMP manufacturing facility. They are currently increasing capacity with the addition of a second 3000L bioreactor train, identical to the existing line. Recent client demand has prompted initial steps in the plan toward build-out of a pre-existing structure anticipated to house two 5000L commercial-ready manufacturing lines. CMC Biologics has also increased headcount by more than 30% at its Seattle site to support the expansion.
