CMC Biologics Completes First Stage of Expansion with Addition of Single-Use Facility
25/08/2010 05:18
PR Newswire
COPENHAGEN, Denmark and SEATTLE, August 25, 2010 /PRNewswire/ --
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.
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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.
About CMC
CMC Biologics (www.cmcbio.com) is a leading contract development and
manufacturing organization that provides fully integrated biopharmaceutical
development and manufacturing services to clients around the world, from its
facilities in Europe and the USA. The company specializes in custom services
for the scale-up and cGMP manufacture of protein-based therapeutics for
pre-clinical, clinical trials and in-market production. CMC Biologics' wide
range of integrated services includes cell line development using its
proprietary CHEF1(R) system, process development and comprehensive analytical
testing. CMC Biologics has fully segregated microbial fermentation and
mammalian cell culture suites and offers both stirred tank and perfusion
production processes. CMC Biologics is located in Copenhagen, Denmark, and
Bothell, Washington, near Seattle.
Jenifer Wheat of CMC Biologics, +1-425-485-1900, jwheat@cmcbio.com
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