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.
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.