Cygnus Technologies, the leading assay and services provider for the detection and characterization of impurities in biopharmaceuticals, announced today a new Antibody Affinity Extraction™ (AAE) method for the detection of individual proteins in biotherapeutic products. A superior alternative to 2D western blot methods, AAE is estimated to be 100 times more sensitive and helps identify individual downstream host cell proteins. AAE also brings the power of mass spectrometric (MS) analysis to impurity determination, testing the reactivity of host cell protein antibodies in a more natural state than can be done with traditional methods.
Cygnus Technologies offers AAE as a service, providing an orthogonal method to basic impurity assays and helping customers meet regulatory requirements. Cygnus effectively created the biotherapeutics impurity testing field as the pioneer in analytical test kits and ongoing development of related products and services.
“Pharmaceutical and biotech companies are developing more and more biotherapeutic drugs and vaccines, and the development of biosimilars (generics) is also on the rise,” explains Ken Hoffman, founder and president of Cygnus Technologies. “The process of testing for impurities in these products is critical because they are grown in live hosts. By providing a faster, more specific and more sensitive alternative to traditional western blot, we can give our customers tools to clear regulatory hurdles faster.”
Technologies develops, manufactures and markets assay kits and related services that enable pharmaceutical and biotech companies to detect and identify host cell impurities in biotherapeutics, an important step in regulatory approval and quality control processes. With products, services and expert advice, Cygnus helps biopharmaceutical companies move new therapeutics more quickly through the development and approval stages to market. With headquarters in Southport, N.C., Cygnus Technologies serves customers worldwide through a global distributor network. A privately held company, Cygnus Technologies was acquired by Maravai LifeSciences in 2016.
David Weber, Chief Commercial Officer