BioGenes launches enhanced generic E.coli host cell protein assay for biomanufacturing

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.

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 immunizing 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.

The E.coli|360-HCP ELISA will be presented at booth 422 at the BioProcess conference held on 26–29 October, 2015 in Boston, MA, USA.