KRIBIOLISA™ CHO HCP ELISA

Bipharma - Others; Other Biopharma / Vaccine ELISA; Contamination / Bioprocess Residue ELISA

Immunoassay for the measurement of CHO Host Cell Proteins

Introduction:
A variety of proteins which are used as therapeutic agents in humans and animals are produced through
recombinant expression in Chinese Hamster Ovary (CHO) cells. The manufacturing and purification process of
these products tends to leave the potential for contamination by Host Cell Proteins (HCPs) from CHO cells,
which may result in adverse toxic or immunological reactions that ultimately affect the efficacy of the therapeutic
agent. The simple, objective and semi-quantitative ELISA is a highly sensitive method that aids in purification
process development, process control, quality control and product release testing optimally.

Intended Use:
This generic KRIBIOLISA™ CHO HCP kit is intended in determining the presence of Chinese Hamster Ovary
Host Cell Proteins contamination in various products that are manufactured through recombinant expression in
CHO cells. The kit has been validated successfully for testing of in process and final product HCPs in variety of
products regardless of growth and purification process.

Principle:
This assay is based on the Sandwich ELISA procedure. Samples containing CHO HCPs are reacted with
already coated affinity purified capture anti-CHO HCP antibody. Following an incubation period unbound
components are removed by a washing step. Then the anti-CHO HCP: HRP is added. This immunological
reaction results in formation of a sandwich complex of solid phase antibody-HCP-enzyme labeled antibody. The
wells are again washed to remove any unbound reactants. The TMB substrate is then added to the well. The
amount of hydrolyzed substrate is read on a microtiter plate reader and it is directly proportional to the
concentration of CHO HCPs present.