Date: 2015-06-30
Type of information: Construction of a production plant
Compound:
Company: CMC Biologics (Denmark - USA)
Therapeutic area: Technology - Services
Type agreement: expansion of a production plant
Action mechanism:
Disease:
Details: * On June 30, 2015, CMC Biologics, a global leader in clinical and commercial manufacturing of monoclonal antibodies and other therapeutic proteins, announced that, as part of its global manufacturing capacity expansion strategy, it 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 2000L production bioreactors and a 2000L seed train, allowing for flexible production with scales from 2000L to 12000L 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 now being prepared for cGMP production of commercial supply in support of a leading customer’s BLA filing and initial product launch in the United States. CMC Biologics’ innovative and flexible solution to manufacturing is enabling its customers to meet accelerated development timelines and commercial launch requirements as well as aggressive regulatory timelines. Customers will also soon have greater manufacturing flexibility in Europe as well. As previously announced in May, the Copenhagen Bioreactor 6PackTMinstallation is scheduled for initial GMP production late 2015, and will consist of a Bioreactor 3Pack™ configuration with three 2,000L single-use production bioreactors and a seed train. Three additional 2,000L bioreactors will be added at a later date to complete the Bioreactor 6Pack™ line, thereby establishing identical Bioreactor 6PackTM facilities in the US and Europe.
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