The company announced today that it has completed the first stage of the expansion for its Copenhagen, Denmark- based manufacturing facility with the addition of a single-use Bioreactor 3PACK facility, currently ready for production runs.
The 3PACK contains three 2,000L single-use production bioreactors and associated seed train for scale up. According to the company, the facility allows for flexible production with scales from 2,000L to 6,000L in a single production suite. Additionally, the bioreactors can be run singly, simultaneously, sequentially, or in staggered mode.
"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 at the Copenhagen Site.
The company plans to add three additional 2,000L single-use production bioreactors in 2017 to establish a Bioreactor 6PACK line identical to the services 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," said Gustavo Mahler, PhD, President and CEO of CMC Biologics. "We are changing the way CMOs operate and we continue to generate innovative solutions for our clients."
As Outsourcing-Pharma.com previously reported, the company received regulatory approval for the upgrades in October 2013. The facility is approved for GMP production by the EMA and is also fully US Food and Drug Administration (FDA) compliant.