CMC Biologics, a global leader in clinical and commercial manufacturing of monoclonal antibodies, coagulation factors and other therapeutic proteins, announced that, as part of its ongoing global manufacturing capacity expansion, it has completed the first stage of the expansion for its manufacturing facility in Copenhagen, Denmark with the addition of a single-use Bioreactor 3PACK facility. The Bioreactor 3PACK configuration consists of three 2,000L single-use production bioreactors and associated seed train for scale up, allowing for flexible production with scales from 2,000L to 6,000L in a single production suite. The bioreactors can be run singly, simultaneously, sequentially or in staggered fashion to achieve desired production needs. The 3PACK line is ready for production runs in June 2016.
“With this additional cGMP production capacity, we are continuing our long-term strategy to provide innovative solutions to our customers, from early-stage development to large-scale commercial production,” said Patricio Massera, general manager of the Copenhagen Site.
With the combination of multiple 2,000L single use bioreactors, CMC Biologics has broken the paradigm that single-use technologies are not applicable for large-scale manufacturing of biologics. Three additional 2,000L single-use production bioreactors will be added in 2017 to complete the fit out of a Bioreactor 6PACK line, thereby establishing identical Bioreactor 6PACK facilities in its US and European manufacturing facilities.
“Establishing this unique facility design in both our US and European manufacturing facilities enables us to significantly optimize process transfer and synergies between the sites. This provides our customers with the production scale and flexibility needed in today’s market, and enables our client to meet aggressive regulatory and production timelines, ”said Gustavo Mahler, PhD, president & chief executive officer of CMC Biologics and added, “We are changing the way CMOs operate and we continue to generate innovative solutions for our clients.”