BioMARC was created to fill an industry need for higher containment biologics manufacturing (BSL-3 and Select Agent cGMP manufacturing). BioMARC full time staff of manufacturing experts, best practice methodology and adherence to quality and validation practices along with our extensive network of professionals throughout Colorado State University (CSU) provides the foundation for which our Contract Manufacturing Organization (CMO) operates. Leveraging our numerous strategic partnerships, and investments in facility infrastructure, we can ensure that any project managed by BioMARC, will receive the attention and highest quality deliverables expected from a CMO providing cutting edge solutions.
CSU, as an institution, has been at the forefront of microbial research since its inception over 100 years ago. Past research experience coupled with industry expertise led to the successful establishment of BioMARC in 2006. Through BioMARC, CSU is able to provide these core GMP manufacturing services to select commercial, private, and government entities.
Process & Method Development
Every client's manufacturing process and methods are unique to their product. BioMARC specialized in recreating those specifications during Technology Transfer in a cost effective and efficient way. We also have the expertise to develop or refine new processes and methods necessary to bring a product through each phase of the product development lifecycle.
High Containment Manufacturing
BioMARC specializes in high containment biologics manufacturing. Our facilities and infrastructure provide a clear and easy path from pre-clinical to GMP commercial manufacturing. Our in-house quality system and EHS procedures enable us to plan for a clean, safe and controlled environment. Click here to learn more.
RECENT NEWS & EVENTS
23 March 2014 BioMARC Awarded a Semi-Automated Fill Finish Project The Biopharmaceutical Manufacturing andf Academic Resource Center (BioMARC) at Colorado State University (CSU) was recently awarded a manufacturing project to provide production infrastructure...... 22 March 2014 BioMARC of Colorado State University approved by FDA The Federal Drug Administration has approved a Colorado State University to manufacture commercial quantities of a biologic product used by health officials to screen for a bacterial infection...... 11 November 2013 BioMARC of Colorado State University Performs PAI The Biopharmaceutical Manufacturing andf Academic Resource Center (BioMARC) at Colorado State University (CSU), has recently completed and inspection by the FDA as part of a planned PAI......