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Set up meetingAnalyses of key protein features, stability and impurity levels
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Enzyme-Linked Immunosorbent Assay (ELISA) is an immunoassay that detects the presence of a specific ligand. The ligand is often a protein, which the assay’s antibodies recognize. Thus, developing a kit of antibodies from a particular ligand pool makes it possible to assess the presence and approximate amount of target proteins quickly.
Therefore, an HCP assay using ELISA is commonly used for performing HCP analysis of biopharmaceuticals. Examples include therapeutic proteins, recombinant peptides, vaccines, monoclonal antibodies (mAbs), antibody-drug-conjugates (ADCs), biosimilars, and gene therapy products.
Steps of a sandwich ELISA: 1) We coat Anti-HCP capture antibodies to the ELISA plate. 2) HCP antigens are added to wells and bind to corresponding antibodies. 3) Detection antibodies are added and bind to antigens. 4) Enzyme conjugate is added and binds to detection antibodies. 5) Finally, a substrate is added, and colorimetric analysis estimates the total HCP concentration.
Despite widespread use, sandwich ELISAs rely on antibody specificity and rarely cover all HCP species in a process step or final product. It is thus essential to validate all ELISA antibodies before using them for Host Cell Protein detection. For this purpose, an HCP ELISA coverage analysis is performed, e.g., by ELISA-MS.
Our setup is suitable for all HCP ELISAs, including those targeting the expression systems:
It is also suitable for individual process reagents, such as human serum albumin (HSA), bovine serum albumin (BSA), and Protein A. Moreover, we work with commercial/generic, process-specific, and platform assays from common HCP kit manufacturers like Cygnus (HEK293), Rockland, Biogenes, etc.
An HCP assay requires both ELISA antibodies and a mock cell lysate or early process sample.
Please get in touch with us for more specific sample requirements before shipment.
