Fort Collins, CO. October 31, 2013 — The Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC) at Colorado State University (CSU) is expanding resources and expertise through the recent acquisition of management responsibilities of a state of the art biologic Good Manufacturing Practice (GMP) facility at the Research Innovation Center (RIC) on CSU’s Foothills campus. Commonly known as the “RIC-GMP” building, the facility represents CSU and BioMARC’s continued dedication toward the advancement and translation of biological products for human use.
As part of CSU’s long term goal to offer product translational services to academic, government, and industry partners for the development and manufacturing of vaccines, therapeutics, and diagnostics this stand-alone cGMP facility was built by CSU. Unique features include:
Upon completion of construction and qualification activities, the GMP operational responsibilities of the facility were turned over to BioMARC to meet its growing needs and expand its capacity in developing biological products. Dr. Rick Lyons, Director if the Infectious Disease Research Center where the RIC –GMP resides, stated that, “BioMARC was a natural fit in the new RIC cGMP building because of their in-house expertise in translating products and because of their track record for success.”
Dr. Dennis Pierro, Director of BioMARC, indicated that the building would foster future opportunities for both BioMARC and for CSU in the novel space of higher containment biologic manufacturing. Dr. Pierro also commented that “BioMARC’s growth mirrors the national need for talented and trained biologic manufacturing professionals, as well as the tremendous need for appropriate facility infrastructure in biopharmaceutical development. It is very encouraging to see that CSU is leading the nation in realizing the need for appropriately sized infrastructure in order to develop and produce biopharmaceuticals for human health. BioMARC will use this new facility to expand its high containment operations to support submissions to US and EU regulatory agencies.”
BioMARC is a nonprofit Contract Manufacturing Organization (CMO) owned and operated by CSU, 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. 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.
BioMARC has expertise in developing and optimizing product manufacturing processes and related tests for therapeutic, vaccines, and diagnostic products. BioMARC specializes in high containment cGMP manufacturing of biologics from preclinical stages through phase I-III and commercial production and has experience in recombinant toxins. Recently, BioMARC’s production areas were inspected by the US-CDC for manufacturing of complex biologics including toxins.