Like other HCP assays the new CHO360 HCP enzyme-Linked immunosorbent assay (Elisa) panel is designed to determine whether or not biopharmaceuticals are contaminated with proteins derived from the Chinese hamster ovary (CHO) cells in which they are produced.
The difference with the new BioGenes technology is that it consists of a panel of four assays and is capable of detecting - what the firm claims is - the ‘broadest possible’ range of CHO antigens of any test currently on the market.
Spokeswoman Dagmar Schwertner-Knoll told BioPharma-Reporter.com that: “Scientists can use the CHO360 ELISA panel during process development rather and then select the most appropriate kit rather than creating a bespoke assay, which is expensive.”
Schwertner-Knoll explained that BioGenes created the CHO360 HCP Elisa panel by immunising rabbits and goats with proteins from a non-transfected HCP cell lines and then collecting the resulting antibodies.
She added that all four assays have a lower limit of detection (LOD) between 0.5–1 ng/ml and a lower limit of quantification (LOQ) is 2–3 ng/ml with a working range between 2–100 ng/ml, meaning they can be used to detect very small amount of CHO proteins.
Schwertner-Knoll acknowledged that later stage clinical development and commercial production require specific assays tailored to individual production process, but stressed that the idea behind BioGenes’ new tech is to help developers get to that point.
“There are many different opinions on when during the development process bespoke HCP assays are needed but most authorities – including the US Food and Drug Administration (FDA) – require them when the biopharmaceutical in question enters PhIII clinical trials.”
Berlin, Germany-based BioGenes plans to market the new assay panel to both biopharma companies and the contract manufacturing organisations they work with.