Bio-Techne Corporation and Cygnus Technologies, part of Maravai LifeSciences announced the launch of the Simple Plex™ HEK 293 HCP 3G assay for automated process impurity testing on the Ella™ immunoassay platform. Purification of viral particles to minimize host cell protein (HCP) contaminants is a crucial aspect of the viral production workflow in cell and gene therapy applications. Accurate quantitation across process steps is needed to ensure HCP impurity clearance is achieved in accordance with regulatory guidelines.

Utilizing a cartridge-based microfluidic design, the new Simple Plex HEK 293 HCP 3G assay provides consistent and controlled assay conditions for HCP detection that is exceptionally accurate and reproducible. The assay features a streamlined hands-free workflow and results in 90 minutes, giving therapeutic developers a robust and convenient tool for HCP impurity quantitation. Unlike traditional immunoassay methods, Simple Plex assays on the Ella platform employ built in calibration to minimize set up time and user dependent variability.

Cygnus Technologies' HEK 293 HCP ELISA Kit, 3G is considered the gold standard in HEK 293 HCP impurity quantification. The antibody used in the kit has been evaluated for reactivity to nearly 3,000 individual HCPs present in HEK 293 strains by antibody affinity extraction and mass spectrometry methods. The kit has been qualified with many viral vector-based drug substances and in-process samples, providing the specificity and sensitivity to detect HEK 293 HCP impurities with reproducibility that supports regulatory compliance.

The Simple Plex HEK 293 HCP 3G assay features the same HEK 293 HCP antibodies from industry leader Cygnus Technologies, ensuring the broad HCP detection coverage and industry recognized specificity of the Cygnus ELISA, along with the workflow advantages of the automated Ella platform.