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Bio-Techne And Cygnus Technologies Announce Partnership For 3G CHO-HCP Assay
MINNEAPOLIS and SOUTHPORT, N.C., Aug. 13, 2019 /PRNewswire/ -- Bio-Techne Corporation and Cygnus Technologies, part of Maravai LifeSciences, announced today a
About this update from Bio-techne Corp
[{"type":"text","content":"MINNEAPOLIS and SOUTHPORT, N.C., Aug. 13, 2019 /PRNewswire/ -- Bio-Techne Corporation and Cygnus Technologies, part of Maravai LifeSciences, announced today a strategic partnership for the quantification of Chinese hamster ovary host cell proteins (CHO-HCP) on the ProteinSimple™-branded Ella™ immunoassay platform. Under the terms of the agreement, Bio-Techne and Cygnus are introducing the co-developed third generation CHO-HCP assay in the proprietary Simple Plex™ immunoassay cartridge for customers in North America and Europe. \nHCP measurements are critical quality-control steps in biopharmaceutical development because the presence of these impurities in the final product can potentially interfere with drug efficacy, induce an undesired immune response or impact drug stability. Regulatory authorities have provided recommendations for biopharmaceutical companies on the removal of HCPs. Biopharmaceutical manufacturers monitor HCPs to demonstrate reproducibility of their purification process, ensure HCP clearance and perform product lot release testing. \nCygnus Technologies' third generation CHO-HCP ELISA Kit has long been considered the gold standard in CHO-HCP impurity quantification. The antibody used in the kit has been evaluated for reactivity to more than 1,000 individual HCPs present in CHO strains by state-of-the-art antibody affinity extraction and mass spectrometry methods. The kit has been qualified with many drug substances and in-process samples, providing the specificity and sensitivity to detect CHO-HCP impurities with reproducibility that supports regulatory compliance. \nThe Ella platform allows users to perform high-quality immunoassays in 90 minutes with no manual intervention. This innovative immunoassay technology enables companies to decrease the iteration time and overhead burden of their process development. \nDave Eansor, president of Bio-Techne's Protein Sciences Segment, commented, \"We are excited about this partnership as it provides the bioprocess community an automated platform-based approach for their impurity testing. Fast and efficient process development and monitoring is crucial for biopharmaceutical companies providing a safe and efficacious product in a cost-effective manner.\" \nKen Hoffman, founder and president of Cygnus Technologies, commented, \"Many of our biopharma customers are develo...