Pichia Pastoris HCP ELISA Assay Kit


The Pichia Pastoris HCP ELISA Assay Kit is a generic kit intended in determining the presence of P. pastoris Host Cell Proteins contamination in various biotechnology products that are manufactured through recombinant expression in P. pastoris. 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. The Pichia Pastoris HCP ELISA Assay Kit is for research use only and not to be used for diagnostic procedures.

Pichia Pastoris HCP ELISA

The Pichia Pastoris HCP ELISA is For Research Use Only

Size: 1 x 96 wells
Calibrator Range: 15.6 – 1000 ng/mL
Sensitivity: 15 ng/mL
Sample Size: 100 uL
Sample Type: Cell Culture Supernatant and other Biological Preparations
Incubation Time: 3 hours 45 minutes

Assay Background

A variety of proteins and pDNA which are used as therapeutic agents in humans and animals are produced through recombinant expression in P.pastoris. The manufacturing and purification process of these products tends to leave the potential for contamination by Host Cell Proteins (HCPs) from P.pastoris 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.

Assay Principle

This assay is based on the Sandwich ELISA procedure. Samples containing P.pastoris HCPs are reacted with already coated affinity purified capture anti-P.pastoris antibody and bind to them. Plates are washed with wash buffer to remove unbound reactants. Anti P.pastoris-HRP conjugate is added which results in the formation of a sandwich complex of solid phase antibody-HCP-enzyme labeled antibody. The wells are washed to remove any unbound reactants as per the wash procedure. The substrate 3, 3’,5, 5’ Tetra Methyl Benzidine is then reacted. The amount of hydrolyzed substrate is read on a microtiter plate reader and it is directly proportional to the concentration of P. pastoris HCPs present.

Related Products:

Protein A ELISA Assay Kit
E.coli HCP ELISA Assay Kit


Product Manual

Please note: All documents above are for reference use only and should not be used in place of the documents included with this physical product. If digital copies are needed, please contact us.

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