BioGenes Launches Enhanced Generic HCP Assay for Early Stage Biologics Production

BioGenes GmbH, a global leader in host cell protein (HCP) assay development, today announced that it has launched a new generic HCP assay with enhanced HCP recovery properties. The CHO|360-HCP ELISA is designed to cover the broadest possible spectrum of antigens by integrating four different assay types. An upfront feasibility test will identify the most suitable ELISA kit thus allowing to greatly increasing HCP recovery.

CHO|360-HCP ELISAs employ antibodies of HCPs from different species. By immunizing rabbits and goats with HCPs of a non-transfected CHO cell line combined with a unique approach for antigen and antibody preparation as well as an optimized purification strategy, BioGenes has developed a panel of four different HCP ELISAs that altogether build up the enhanced generic CHO|360-HCP Assay.

Dagmar Schwertner-Knoll, Marketing Director of BioGenes GmbH said: “Our strategy is to offer different ELISA kits for HCP detection. An upfront feasibility test, performed by the customer or by BioGenes as a service, enables the selection of the most suitable kit for a specific process and greatly increases the HCP recovery for most samples.”

For all four assay types the lower limit of detection (LOD) is between 0.5–1 ng/ml and the lower limit of quantification (LOQ) is 2–3 ng/ml with a working range between 2–100 ng/ml. A high specificity for the antigen in all four assays was determined by 2D western blotting with the respective antibodies.