BioGenes Launches Enhanced Generic E.coli Host Cell Protein Assay for Biomanufacturing

Berlin, Germany, October 27, 2015 / B3C newswire / -- BioGenes GmbH, a global leader in host cell protein (HCP) assay development, today 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 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 Oct 26-29, 2015 in Boston, MA, USA.

About BioGenes
BioGenes GmbH specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.


Dagmar Schwertner-Knoll
Marketing/Sales Director
BioGenes GmbH
[email protected]