CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
At the AACC show 2016
October 2016—Binding Site’s Immunological Group announced the addition of two rubella antigens and a cytomegalovirus antigen along with the availability of special protein reagents to in vitro diagnostic manufacturers.
The rubella antigens are derived and sourced from infected cells, via culture, which are then treated by UV irradiation to inactivate the pathogenic components. The ultra-purified and ultra-sensitive variant is ideal for the detection of IgM antibodies. The antigens are designed to benefit the needs of biopharmaceutical, clinical, and life science researchers, as well as manufacturers of IVD test kits, and exhibit exceptional purity levels as a result of cross-flow, ultra-filtration and centrifugation techniques.
The CMV antigen, for biopharmaceutical, clinical, and life-science research applications and for IVD manufacturing procedures, is derived and sourced from infected cells, where the pathogenic components are inactivated via β-propiolactone treatment. The antigen exhibits exceptional purity levels as a result of polishing techniques.
The CMV and rubella antigens have been expressly designed for use as an integral component within solid phase ELISA-based immunoassay test procedures. They display the highest degrees of activity and specificity, demonstrate exceptional lot-to-lot consistencies, claim a shelf-life stability of 10 years from the manufacturing date, and are available in 1.0 mg and 0.25 mg fill-sized vials with larger, bulk configurations also available.
Bulk reagent manufacturing services to IVD suppliers and manufacturers are now available for a broad menu of special protein assays. By using the same techniques and manufacturing procedures used to manufacture its own clinical materials, Binding Site’s Immunologicals Group can assist IVD companies by providing tailored, bulk manufacturing solutions that will enable companies to deliver reliable clinical reagents to the marketplace. The range of special protein testing reagents include those involved in the areas of general metabolic health, analyte and component transport, anemia, active infection, tissue inflammation, immune response and status, nutritional assessment, and other varied disease states. Binding Site’s reagent manufacturing facilities maintain registration to ISO 9001:2008 quality management systems and ISO 13485:2003 medical devices quality management systems and are subject to audit and inspection by numerous quality and regulatory agencies.
Binding Site, 800-633-4484