Bio-Techne Corporation launched 3G assay for automated process impurity assessment on the EllaTM immunoassay platform ( NASDAQ: TECH ) and Cygnus Technologies, a division of Maravai LifeSciences ( NASDAQ: MRVI ).
In cell and gene therapy applications, the purification of viral particles to reduce host cell protein (HCP) contamination is an important part of the viral production workflow. To guarantee HCP impurity clearance is performed in compliance with regulatory criteria, accurate quantification throughout process phases is required.
The novel Simple Plex HEK 293 HCP 3G test uses a cartridge-based microfluidic design to deliver uniform and controlled assay conditions for HCP detection that is extremely accurate and reproducible. The test has a hands-free procedure and provides data in 90 minutes, providing pharmaceutical developers with a reliable and convenient tool for HCP impurity quantification. Simple Plex assays on the Ella platform, classic immunoassay methods, provide built-in calibration to reduce set-up time and user-dependent variability.
The gold standard in HEK 293 HCP impurity quantification is Cygnus Technologies' HEK 293 HCP ELISA Kit, 3G. With high-tech antibody affinity extraction and heavy spectrometry procedures, the kit's antibody was tested for reactivity to almost 3,000 distinct HCPs present in HEK 293 strains. The kit has been tested with various viral vector-based medicinal compounds and in-process samples, demonstrating that it possesses the specificity and sensitivity to detect HEK 293 HCP contaminants with the reproducibility needed to meet regulatory requirements. The Simple Plex HEK 293 HCP 3G assay uses the same HEK 293 HCP antibodies from market leader Cygnus Technologies, ensuring the Cygnus ELISA's extensive HCP detection coverage and industry-recognized specificity, as well as the automated Ella platform's workflow advantages.
We continue to enjoy the fruits of the Bio-Techne-Cygnus Technologies partnership as it provides the therapeutic development and manufacturing community an automated platform-based approach for HEK 293 host cell 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."
Will Geist, President of Bio-Techne's Protein Sciences Segment.