When protein –based biotherapeutics first came to the market the importance of purity was the highest outmost 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 succeed.
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.
Our mission is to provide our customers with innovative products of the highest quality, enabling them to efficiently develop and manufacture safe and efficacious products. We can achieve this by developing 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.
Sterogene Bioseparations is a privately held company headquartered in Carlsbad, California just a short distance north of San Diego. Founded in 1985 to develop and manufacture stable, NaOH sanitizable affinity chromatography resins that are used in the purification of human blood products and biopharmaceuticals, the company has evolved into being a key supplier of chromatography resins and services to some of the world’s largest biopharmaceutical companies. We have also developed resins that are approved by the FDA for use in medical devices. Our products are also included in extracorporeal devices and we have built a significant amount of technical support regarding biocompatibility characterization and regulatory support.
However, lots 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.
Sterogene Bioseparations, Inc.
1949 Kellogg Avenue Carlsbad, CA 92008
United States of America
Telephone: +1 760 929 0455