Cygnus Technologies, a Maravai LifeSciences company, announces an expansion of its service offerings for host cell protein (HCP) analysis. A pioneer in tools for the detection of HCP impurities in biopharmaceuticals and vaccines, Cygnus now offers services to identify and quantify those impurities, which can impact the efficacy and stability of the therapeutic.
Regulatory groups are increasingly asking biopharmaceutical companies to use advanced methods that are orthogonal to the standard ELISA, to quantify and characterize HCPs that might be present in the biologic under development. Mass spectrometry, with its high sensitivity, combined with Cygnus’ proprietary antibody affinity extraction (AAE) sample preparation method, is an ideal tool for this next stage of analysis. AAE enriches the HCPs by as much as 240 times, making it possible to detect low-abundance, problematic HCPs with mass spectrometry.
“Many of our biopharma customers are already outsourcing the detection and sample prep (AAE) steps to us,” explained Ken Hoffman, founder and president of Cygnus. “With the regulatory push for much more information on the HCPs present, even more customers are looking to outsource. Many do not have expensive mass spectrometers in their labs or mass spec teams on staff to handle these specialized analyses.
“Pharmaceutical and biotech companies are developing more and more biotherapeutic drugs and vaccines, and the development of biosimilars (generics) is also on the rise,” continues Hoffman. “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 way to measure impurities, we can give our customers tools to clear regulatory hurdles faster.”
About Cygnus Technologies
Cygnus 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 quickly move new therapeutics through the development and approval stages to market. With headquarters in Southport, N.C., Cygnus Technologies serves customers worldwide through a global network. A privately held company, Cygnus Technologies was acquired by Maravai LifeSciences in 2016.
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