cGMP Manufacturing of High Containment Biologics
The Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC) at Colorado State University (CSU) is a world class production facility utilizing some of the most up to date technologies in biologics containment and cGMP product manufacturing. We specialize in the production of biological products that require higher containment infrastructure, in particular Biosafety Level (BSL) 3 organisms, CDC Tier 1 Select Agents, as well as microbial spore formers.
BioMARC stands apart by having an end-to-end infrastructure to assist your cGMP project needs for the development, pre-clinical, clinical and/or commercial level (FDA inspected) products.
Key features of BioMARC include:
- A well-integrated Business Development Unit that will build a plan for success.
- A strong Project Management Unit that will facilitate the efficient and uninterrupted progression of your project.
- An experienced in-house Quality Unit (QA and QC) to meet high quality and regulatory standards.
- A Manufacturing Unit that oversees multiple BSL-2/3 ISO-5/7/8 cGMP suites that will produce your product to cGMP standards, including validation.
- A dedicated Facilities Unit that will keep the entire cGMP environment (HVAC, Equipment, BMS, etc.) qualified and in compliance.
- A Process Development Unit (with BSL-3 development laboratories) to help transition your product into GMP and to develop both processes and methods (characterization, in-process and/or release) toward validation.
- FDA-Inspected Experienced staff that can facilitate the Phase III and Commercial-Level complexities of product manufacturing.
BioMARC is dedicated to assist in every way possible to the fulfillment of your product manufacturing lifecycle milestones. Furthermore, the goal of the BioMARC is to provide an opportunity for academic, government, and private sector researchers to engage in cutting-edge product development activities with a focus on infectious disease agents and we welcome all opportunities to this end.
You are encouraged to use this web site to explore our programs and people, and please do not hesitate to call, write, or e-mail me.
John H. Wyckoff III, PhD