Fort Collins, CO. November 11, 2013 — Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC) of Colorado State University (CSU), has recently completed an inspection by the US Food and Drug Administration (FDA) as part of a planned preapproval inspection (PAI) for a biological product license.
This PAI activity by the FDA is the culmination of a successful manufacturing project by BioMARC on behalf of one of their clients. At the completion of the inspection, Dr. Dennis Pierro, Director of BioMARC, praised his staff for their outstanding efforts and for their seamless and thorough agency interactions as well as their ability to present a GMP facility receiving its first product manufacturing inspection. Dr. Pierro also commented that “[t]he inspection went very well and I believe the inspection team was very impressed with our thoroughness and attention to detail. Now with this PAI behind us the staff at BioMARC, are dedicated to support the continuous improvement paradigm of cGMP in all future projects”.
Kathleen Delehoy, Senior Associate Vice President for Research at CSU stated, “[t]his first-ever PAI inspection at CSU is a huge accomplishment for the BioMARC team and CSU. It signifies that BioMARC has a highly accomplished and professional team with a robust Quality System in place. It also demonstrates that BioMARC is moving in the right direction when it comes to cGMP Manufacturing of Biologic products, in particular the BSL-3 manufacturing.”
BioMARC is a nonprofit Contract Manufacturing Organization (CMO) owned and operated by CSU, created to produce biopharmaceutical products for non-clinical, clinical, and commercial use under Biosafety Level 3 (BSL-3) and BSL-2 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 expertise in developing and optimizing product manufacturing processes and related tests for therapeutic, vaccines, and diagnostic products. BioMARC specializes in high containment cGMP manufacturing of biologics from preclinical stages through phase I-III and commercial production and has experience in recombinant botulinum toxins. Recently, BioMARC’s production areas were inspected by the US-CDC for manufacturing of complex biologics including toxins.