WA: CMC Biologics Expands GMP Manufacturing Capacity in the United States
1 Jul, 2015
CMC Biologics, Inc., a global leader in clinical and commercial manufacturing of monoclonal antibodies and other therapeutic proteins, announced, 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 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.
"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 6PackTM facility is a prime example of how CMC Biologics provides innovative solutions for our clients."
About CMC Biologics
CMC Biologics is leading the industry among CMOs in reliability, technical excellence, and quality — Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production. The Company's wide range of integrated services includes cell line development, bioprocess development, formulation development, and comprehensive analytical testing. Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. More detailed information can be found at www.cmcbiologics.com.