CMC Biologics Completes Expansion of US FacilityBy
CMC Biologics, Inc., a provider of clinical and commercial manufacturing services for monoclonal antibodies and other therapeutic proteins, has completed the expansion of its North American manufacturing facility in Bothell, Washington with the addition of a single-use Bioreactor 6Pack facility. The Bioreactor 6Pack configuration consists of six 2000-L production bioreactors and a 2000-L seed train, allowing for flexible production with scales from 2000 L to 12000 L in a single production suite. The bioreactors can be run in single unit operations or in groups, simultaneously, sequentially or in staggered fashion to achieve desired production needs.
The Bioreactor 6Pack facility in Bothell is being prepared for cGMP production of commercial supply in support of a customer’s biologics license application filing and initial product launch in the United States.
In Europe, the Copenhagen Bioreactor 6P ackTMinstallation is scheduled for initial GMP production in late 2015, and will consist of a Bioreactor 3Pack configuration with three 2,000-L single-use production bioreactors and a seed train. Three additional 2,000-L bioreactors will be added at a later date to complete the Bioreactor 6Pack line, thereby establishing identical Bioreactor 6Pack facilities in the US and Europe.
CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes.
Source: CMC Biologics