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.

"Our combined capabilities will provide a fully-integrated, one-stop manufacturing solution for the accelerated preclinical, manufacturing, and clinical testing of biological therapeutics, novel vaccines, and diagnostic products intended for use in humans," said Raymond Goodrich, PhD, executive director, infectious disease research center, BioMARC.