BioMARC has extensive expertise in developing and optimizing product manufacturing processes and related tests for therapeutic, vaccines, and diagnostic products. To-date, BioMARC has brought a diagnostic parenteral product through clinical trial and commercial production (including a PAI inspection), 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 in non-human primates bridging to a phase I study in humans.
BioMARC is a nonprofit CMO owned and operated by CSU, and 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.
About Colorado State University
Colorado State University, founded in 1870, is now among the nation's leading research universities. CSU conducts world-class research in infectious disease, atmospheric science, clean energy technologies, environmental science, and biomedical technology which attracts more than $300 million in research funding annually. Our professional programs in veterinary medicine, occupational therapy, journalism, and agriculture and construction management are ranked among the nation's best.
CSU desires to create strong collaborative relationships with academic, governmental commercial research and development organizations that serve to provide advancement in human health and science. BioMARC is that mechanism for furthering the mission of CSU by providing a biologics clinical phase 1-3 and commercial manufacturing division that supports translational research and provides services that can help fill the needs of manufacturing high containment products in a cGMP environment.