Fort Collins, CO. March 22, 2014 — The Federal Drug Administration has approved Colorado State University to manufacture commercial quantities of a biologic product used by health officials to screen for a bacterial infection.
CSU’s Biopharmaceutical Manufacturing and Academic Resource Center – or BioMARC – received FDA approval in March after undergoing an inspection last year. The facility is now producing the material for a private sponsor.
“This approval to produce commercial batches of a regulated biologic product is a significant milestone for CSU and BioMARC and speaks to our ability to handle large R&D and commercial projects,” said Dennis Pierro, BioMARC’s Director and a CSU professor.
This is the first time BioMARC, a contract manufacturing facility launched by CSU in 2006, will produce a biologic product or pharmaceutical drug in commercial quantities.
Until now, the facility has primarily tested drugs under development, made small batches for use in clinical trials and worked with companies to improve production.
BioMARC specializes in manufacturing services of biologic products that the U.S. Centers for Disease Control and Prevention requires be handled in at least a Biosafety Level 3 facility.
Pierro said the project is an example of how CSU and BioMARC are aiding people around the world. “CSU and BioMARC continuously seek projects that combat infectious diseases worldwide,” he said. “This approval shows that we can deliver on our mission to have a major impact on human health globally.”
BioMARC is a nonprofit Contract Manufacturing Organization (CMO) owned and operated by CSU and part of the Infectious Disease Research Center (IDRC) on the foothills campus. It was created to produce biopharmaceutical products for non-clinical, clinical, and commercial use under Biosafety Level 3 (BSL-3) and BSL-2 containment and Select Agent (SA) biosecurity conditions. BioMARC has expertise in developing and optimizing product manufacturing processes and related tests for therapeutic, vaccines, and diagnostic products. Recently, BioMARC’s production areas were inspected by the US-CDC for manufacturing of complex biologics including toxins. In addition to manufacturing and testing services, BioMARC offers product and process development services, which includes the creation of development programs focused on implementation of cGMP regulations and scalability issues.