CMC Biologics Expands Its Bothell, Washington, Manufacturing Hub
The company increased the plant’s capacity 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, company officials said. 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.
The company is also expanding its capacity in Europe, with instillation of a Copenhagen Bioreactor 6Pack.
"Establishing this unique facility design in both the U.S. 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 facility is a prime example of how CMC Biologics provides innovative solutions for our clients."
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