BioMARC is a non-profit CDMO owned and operated by CSU, created to translate and produce biopharmaceutical products for non-clinical, and clinical use under Biosafety Level 3 (BSL-3) and BSL-2 containment (including spore former containment) and Select Agent (SA) Tier 1 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.

BioMARC has extensive expertise in developing and optimizing product manufacturing processes and related tests for therapeutics, vaccines, and diagnostic products. Some examples of projects at BioMARC

• Brought a diagnostic parenteral product through clinical trial and commercial production (including a PAI inspection)
• Manufactured a viral 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
• Established a controlled process for manufacturing a therapeutic product for preclinical studies in non-human primates bridging to a phase I study in humans.

Every client’s manufacturing process and methods are unique to their product. BioMARC specializes in recreating those specifications during Technology Transfer in cost effective and efficient ways. We have the expertise to develop or refine new processes and methods to bring a product through each phase of the life cycle.

BioMARC specializes in high containment biologics manufacturing. Our facilities and infrastructure provide a clear and easy path from pre-clinical to GMP manufacturing of Phase I or Phase II material suitable for human clinical trials. Our in-house quality system and EHS procedures enable us to plan for a clean, safe, and controlled environment.

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 $570 million in research funding annually. Our professional programs in veterinary medicine, occupational therapy, journalism, agriculture, and construction management are ranked among the nation’s best.

CSU desires to create strong collaborative relationships with academic, governmental, nonprofit, and commercial research and development organizations that strive for advancement in human health and science. BioMARC is CSU’s mechanism for furthering this mission by providing a clinical Phase I and II biologics manufacturing division that supports translational research. BioMARC provides services that can help fill the needs of manufacturing high containment products in a cGMP environment.

For more information please visit: https://www.colostate.edu/