Cygnus CHO HCP ELISA 3G: The gold standard in CHO HCP analysis

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Expression of therapeutic proteins in CHO cells is a cost-effective method for production of commercial therapeutic mAbs and recombinant proteins. The manufacturing and purification process of these products leaves the potential for impurities by host cell proteins (HCPs) from CHO cells. The CHO HCP ELISA Kit, 3G (F550-1) can be used as a process development tool to monitor the removal of host cell impurities as well as for routine product release testing. The kit has been extensively qualified with many drug substances and in-process samples. Antibody affinity extraction (AAE), a type of immunoaffinity chromatography, demonstrated that the anti-CHO antibody is reactive to more than 1500 individual HCPs from conditioned media and cell lysates in both currently used CHO strains. These 1500+ HCPs represent more than 98% of the total mass of protein as indicated by orthogonal to ELISA protein detection methods. This ELISA is also more robust than the earlier generation kits, as it demonstrates less sample matrix interference and improved dilution linearity. The kit contains all components to evaluate the presence of HCP impurities in 96 samples, including a set of calibrated CHO HCP standards.

Benefits of the The CHO HCP ELISA Kit

• The most sensitive CHO HCP ELISA kit on the market: LOD ~0.3 ng/ml, LOQ ~1 ng/ml
• Qualified by comprehensive orthogonal methods
• Based on HCP antibody with the broadest coverage and reactivity to HCPs that persist through the downstream purification process
• Robust performance supported by decades of in-house technical expertise
• Ease of use across multiple analysts
• Seamless transfer from purification process development to QC testing and to lot release testing
• Supports multiple commercialized biologics

Cygnus Technologies has established proprietary technologies to obtain antibodies and develop robust assays that react to the most important HCPs: those that co-purify with your drug product. The coverage of the CHO HCP antibodies to the CHO HCP antigen from CHO-S and CHO-K1 strains was determined to be ~86% by Antibody Affinity Extraction (AAE) with 2D-PAGE/Silver Stain, and 97% by AAE-MS. More importantly, Cygnus Technologies has successfully evaluated performance of the CHO HCP Antibodies (3G-0016-1-AF) in the 3G CHO HCP ELISA (F550-1) using a panel of CHO samples from several independent biomanufacturing processes.

The F550-1 CHO 3G” HCP ELISA detected HCPs in the range of 100 parts per billion for a variety of therapeutic antibodies and other – biologics expressed in CHO cells. This data supports use of this ELISA kit as a truly generic method that can likely be validated as not only a process development tool, but in most cases as a lot release test, eliminating the need to develop a custom or process specific assay.

Get started with the Gold Standard CHO HCP ELISA

For information on HCP ELISA qualification and antibody please contact us.

Check out Cygnus recent article in BioProcess International on advanced characterization of their anti-CHO HCP antibody using LC-MS: https://www.bioprocessintl.com/sponsored-content/advanced-characterization-of-hcp-polyclonal-antibodies-combining-antibody-affinity-extraction-and-mass-spectrometry