The BioMARC is a contract manufacturing organization producing biologics/biopharmaceuticals. We have a speciality in producing cGMP products (drug substance and drug product) for both clinical and commercial use under Biosafety Level 3 (BSL-3) containment and Select Agent biosecurity conditions. If you want to grow a BLS-3 or SA microbe under cGMP conditions, we can help you.
We have two dedicated cGMP/BSL-3 suites as well as BSL-2 processing rooms. We also have disposable fermentors (WAVE technology), cGMP autoclave (pure steam) as well as many other qualified pieces of equipment. We also have a fully functioning quality manual supported by a quality assurance unit, and a quality control unit capable of performing QC testing services (in process and release).
We contract the rooms and equipment, as well as our BSL-3 and SA approved/trained manufacturing staff, to clients looking for a high quality CMO.
In addition to manufacturing and testing services (including cell bank testing services), BioMARC offers process development services, which includes the creation of development protocols/reports. Assays can be qualified through qualification protocols/reports.
To learn more, please vist our RMRCE-PDM Core web site
For further information, please contact Dennis Pierro at (970)491-8954 or Dennis.Pierro(at)colostate.edu