26-Aug-2010 - CMC Biologics A/S

CMC Biologics Completes First Stage of Expansion with Addition of Single-Use Facility

CMC Biologics 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."

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.

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