Sterogene Bioseparations

Sterogene Bioseparations is a private, established player in the bioprocessing sector, founded in 1990 and headquartered in San Marcos, California. The company's core offering is a portfolio of chromatography resins, with a flagship patented technology called Direct Capture™ that allows for purification directly from unclarified feed streams, streamlining downstream processing. It operates cGMP and ISO 9001-certified manufacturing, maintains regulatory filings with the FDA, and serves customers in biologics and blood product purification through a combination of standard products and custom resin development. Sterogene is positioned as a specialized provider helping to improve yield and reduce costs in next-generation therapy manufacturing.

Patented Direct Capture™ technology using large-porosity Cellthru™ BigBeads for purification from unclarified feed, plus a suite of custom and standard agarose-based chromatography resins for affinity, gel filtration, and extracorporeal devices.

Sterogene competes in a market dominated by global giants like Cytiva (Danaher), Thermo Fisher Scientific, and Merck KGaA. Its competitive advantage lies in its specialized, patented Direct Capture™ technology, concierge-style custom development services, and deep expertise in niche applications like plasma purification and extracorporeal devices, rather than competing on breadth of portfolio.