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We develop and manufacture stable, NaOH-sanitizable affinity chromatography resins used in the purification of human blood products and biopharmaceuticals

Sterogene has evolved into a key supplier of chromatography resins and services to some of the world’s largest biopharmaceutical companies. Our resins are used in the production of FDA-approved biopharmaceuticals and in extracorporeal medical devices. Many of our affinity resins are NaOH-sanitizable. Our Etox (endotoxin-removal) resins excel in the final polishing steps of any purification procedure. We also offer specialty resins and ligand development services using our advanced in silico bioinformatics technologies. 
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Advantages of Sterogene resins

Sterogene Bioseparations provides high quality resins for the production of therapeutic proteins and development of medical devices. Our resins are optimized to meet the following criteria:

Biocompatible We use solid-phase agarose that has been specially selected for biocompatibility.  Our immobilization chemistries are extremely stable with no detectable levels of leakage; harmful chemical residues and entities are completely washed from the solid phase structure.
Autoclavable Whenever possible, we design the agarose beads so that they may be autoclaved prior to ligand immobilization.
Gamma sterilizable Our agarose resins can be sterilized using gamma radiation, although minor discoloration may occur.
ISO 9001:2008 Sterogene Bioseparations is certified ISO 9001:2008 compliant.
Regulatory Support File We can provide detailed Regulatory Support Files related to our resins upon request.
Large scale production We design our resins with large-scale manufacturing in mind, ensuring that your project can be scaled up from R&D inception to full-scale manufacturing.
Confidential We guarantee terms of strictest confidentiality and will happily send you our standard mutual Confidential Disclosure Agreement (CDA).