CMC Biologics expands GMP manufacturing capacity in Europe
Addition of a Bioreactor 3PACK production facility to its Copenhagen facility provides additional flexible solutions for clients.
CMC Biologics, a global leader in clinical and commercial manufacturing of monoclonal antibodies, coagulation factors and other therapeutic proteins, has 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 2000 L single-use production bioreactors and associated seed train for scale up, allowing for flexible production with scales from 2000 L to 6000 L 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 2000 L single use bioreactors, CMC Biologics has broken the paradigm that single-use technologies are not applicable for large-scale manufacturing of biologics. Three additional 2000 L 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, President and CEO of CMC Biologics and added, "We are changing the way CMOs operate and we continue to generate innovative solutions for our clients."
Related News
-
News Swiss pharma industry warns US tariffs could harm global patient care
The Swiss pharmaceutical sector has raised alarms over new US tariffs on medicines, warning of disrupted supply chains, increased costs, and delayed innovation, all of which could jeopardise patient access to essential treatments worldwide.
-
News Women in Pharma: CPHI India – India’s Pharmaceutical Industry and Gender Inclusion Challenges
India’s pharmaceutical industry has emerged as a significant player in the global market, valued at USD 50 billion in FY 2023-2024, according to Frost & Sullivan’s analysis. This sector encompasses a diverse portfolio, including drugs, vacc... -
News Biogen acquires Apellis Pharmaceuticals to boost immunology and rare disease profile
Biogen Inc. has announced its acquisition of Apellis Pharmaceuticals, Inc., a move that is set to significantly enhance its growth portfolio in immunology and rare diseases. The agreement, valued at approximately US$5.6 billion, will see Biogen purchas... -
News Gilead Sciences acquires Ouro Medicines for over US$2 billion
Gilead Sciences confirms a deal to take over Ouro Medicines, adding to a portfolio of therapies for autoimmune diseases.
-
News Women in Pharma: Advancing Women's Health
Discover the latest innovations in technologies and therapeutics that are revolutionising women's health in our latest CPHI Online Women in Pharma infographic.
-
News CPHI Pharma Awards 2026: Recognising Excellence in an Evolving Industry
Submissions now open — deadline May 16
-
News Dr Reddy's to launch generic semaglutide in India
Dr Reddy’s Laboratories, one of India’s leading pharmaceutical companies, is preparing to launch a generic version of semaglutide, branded as Obeda, in March. Obeda is expected to provide a more affordable alternative to Ozempic a... -
News Frontier Biotech and GSK Forge RNA Therapy Partnership
Frontier Biotechnologies and GSK have entered a global licensing agreement to advance small interfering RNA (siRNA) therapeutics. This collaboration grants GSK exclusive rights to develop and commercialise two promising siRNA candidates, marking a mile...