CMC Biologics expands GMP manufacturing capacity in the US

Bioreactor 6Pack facility provides flexible solutions for Phase III and commercial production

CMC Biologics, a Denmark-headquartered manufacturer of 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 2,000 L production bioreactors and a 2,000 L seed train, allowing for flexible production with scales from 2,000 L to 12,000 L in a single production suite. The bioreactors can be run in single unit operations or in groups, simultaneously, sequentially or staggered to achieve desired production needs.

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

The Bioreactor 6Pack facility in Bothell is now being prepared for cGMP production of commercial supply in support of an unnamed customer's BLA filing and initial product launch in the US.

Customers will also soon have greater manufacturing flexibility in Europe. As previously announced in May, the Copenhagen Bioreactor 6Pack installation is scheduled for initial GMP production 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 6PackTM facilities in the US and Europe.

Mahler added: 'Establishing this unique facility design in both the US and European facilities enables us to significantly optimise the process transfer capabilities and synergies between the sites, ultimately providing customers with the production scale and flexibility needed in today's market, and the advantage of meeting aggressive regulatory and production timelines.'

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