BioMARC
Pharmaceuticals - , Colorado, United States
BioMARC Details
BioMARC (Biopharmaceutical Manufacturing & Academic Resource Center) is a nonprofit Contract Manufacturing Organization (CMO) owned and operated by Colorado State University (CSU). BioMARC was created to translate and produce biopharmaceutical products for non-clinical, clinical, and commercial use under Biosafety Level 3 (BSL-3) and BSL-2 containment (including spore former 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 extensive expertise in developing and optimizing product manufacturing processes and related tests. To-date, BioMARC has brought a diagnostic parenteral product through clinical trial and commercial production, manufactured a virus vaccine for a phase I clinical study, established several master and working cell banks, developed and qualified cell based and analytical assays for product testing and release, and established a controlled process for manufacturing a therapeutic product for preclinical studies.MISSION: To serve CSU's needs in research, service, and the translation of new discoveries into products to impact the world at large. BioMARC will leverage the renowned CSU research expertise within the Infectious Disease Research Center and the greater CSU community, together with strategic partnerships to accelerate the development, manufacturing and commercialization of biologic products, from the bench to the bedside. BioMARC will implement the highest quality and regulatory standards in all phases of product development and cGMP manufacturing processes, including preclinical, clinical (Phase I-III) and commercial level manufacturing to accomplish this mission well aligned to CSU's objectives in public service, economic development, and positive global impact.
