CMC Biologics expands North American manufacturing facility with addition of Bioreactor 6Pack facility

Jun 30 2015

CMC Biologics, Inc., a global leader in clinical and commercial manufacturing of monoclonal antibodies and other therapeutic proteins, announced today 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.

"With this additional commercial capacity, we are realizing our long-term strategy to provide innovative solutions to our customers, from early-stage development to large-scale commercial production." said Gustavo Mahler, PhD, Global Chief Operations Officer of CMC Biologics.

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 6Pack^TMinstallation 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 6Pack^TM facilities in the US and Europe.

"Establishing this unique facility design in both the US and European facilities enables us to significantly optimize the process transfer capabilities and synergies between the sites, ultimately providing customers the production scale and flexibility needed in today's market, and the advantage of meeting aggressive regulatory and production timelines," Dr. Mahler added. "We are changing the way CMOs operate and our novel Bioreactor 6Pack^TM facility is a prime example of how CMC Biologics provides innovative solutions for our clients."