Company
Our mission is to provide our customers with innovative chromatography products of the highest quality, enabling them to cost-effectively develop and manufacture biologicals.
We also develop custom purification products that meet the regulatory requirements of governing bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), while allowing significant cost-saving for our customers.
Company Background
Sterogene Bioseparations is a privately held women-owned small business headquartered in Carlsbad, California just a short distance north of San Diego. Founded in 1985 to develop and manufacture innovative, highly stable, sanitizable affinity chromatography resins. Our resins are used in the production of several licensed biopharmaceuticals and diagnostic products., Sterogene has evolved into being a key supplier of chromatography resins and services to some of the world’s largest biopharmaceutical and diagnostics companies. Our resins are used in affinity apheresis medical devices and are used in the treatment of patients with Covid 19 infections, MI, strokes, etc. . We have built significant technical and regulatory support.
A lot of our customers are small and medium-size biotech R&D or academic laboratories. We support their process development and purification needs with chromatography resins of different sizes to meet the needs worldwide.
When protein-based biotherapeutics first came to the market the importance of purity was the highest utmost objective and the cost was not the major factor. We are living in the age of biosimilars where the purity is given but the cost of production is critical to success. Sterogene’s focus is to provide chromatography resins and other products that can result in significant savings to our customers.
Our resins are extremely stable, NaOH cleanable and provide long cycle life.
We have resins that are validated for over 100 cycles and used in the production of licensed pharmaceuticals.
Our Direct Capture technology saves significant cost for our customer due to elimination of costly filtration steps and overall resulting in higher purity and lower production time.