CSSi LifeSciences and BioMARC Partner to Accelerate Biologics Manufacture

The Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC), a nonprofit contract manufacturing service unit owned and operated by Colorado State University, announced it will work with CSSi LifeSciences to map out clinical development solutions and guidelines for cost-effective good manufacturing practices (GMP).

So far, BioMARC has “brought a diagnostic parenteral product through clinical trial and commercial production (including PAI [preapproval inspection]), manufactured a virus vaccine for a Phase I clinical study, established several master and working cell or virus banks, developed and qualified cell-based and analytical assays for product testing and release, and established a controlled process for manufacturing a vaccine product for preclinical studies in non-human primates bridging to a Phase I study in humans,” according to a press release.

CSSi has performed similar lifecycle management tasks for clients, and says it has helped with the development of more than 500 medical products, including biologics.