Enhanced Generic E.coli Host Cell Protein Assay for Biomanufacturing Launched

BioGenes GmbH have announced that it has launched a generic HCP assay with improved HCP recovery properties for E.coli cells. The E.coli|360-HCP ELISA allows sponsors and biotech companies to postpone the development of a cost-intensive specific HCP assay until a more informed decision on the success of a biologic in development can be made.

The E.coli|360-HCP ELISA has been developed using the 360-HCP ELISA approach. While traditional generic HCP assays provide just one single antibody that must work for all processes the generic 360-HCP ELISA provides several kits, each using a different anti-HCP antibody so sponsors can try multiple antibodies to find the one that works best for their samples. An upfront performance test identifies the most suitable ELISA kit thus allowing to greatly increasing HCP recovery.

Dagmar Schwertner-Knoll, Marketing Director of BioGenes GmbH said: “We have evaluated the new generic HCP ELISA for E.coli extensively. For all samples tested we found that at least one of the four kit types was superior to the competitor kit.”

E.coli|360-HCP assay is based on W3110 and BL21 (DE3) cell lines which were fermented in different culture media and temperatures resulting in four antigen preparations with distinct HCP patterns. By immunising goats with these antigens, BioGenes has developed a panel of four different HCP ELISAs that together build up the enhanced generic E.coli|360-HCP assay.

For all four assay types the lower limit of detection (LOD) is between 0.2–0.5 ng/ml and the lower limit of quantification (LOQ) is 0.6–1.6 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.