charles river CHO-HCP ELISA Kit

CHO-HCP ELISA Kit

Introducing the world’s first IgY based CHO-HCP ELISA kit specifically designed to close the detection gaps in your impurity testing. By leveraging our extensive in-house experience and comprehensive end-to-end solutions, we’ve developed and patented a novel HCP kit capable of detecting up to 90% of the HCP proteins present in the sample.

Specific

• Coverage 90%
• Continuously possible to develop the HCP assay method for Phase 3
• Fast Delivery

CHO-Host Cell Protein ELISA Kit Product Information

• Storage: All kit reagents 2 °C to 8 °C
• Target Expression System: CHO
• Species Group: Mammalian
• Species: Chinese hamster
• Assay format: 96 Well Plate
• Time to result: ~3 hours
• LOD: 0.1 ng/mL
• LLOQ: 2 ng/mL
• Minimum Diluent: 1:2
• Antibody Coverage: 90%
• Package Insert
• Terms and Conditions

What Makes IgY Antibodies an Attractive Alternative for CHO-HCP ELISA Kits

In contrast to other commercially available mammalian IgG based host-cell protein kits, our CHO-HCP ELISA kit leverages the avian IgY antibody, specifically, those found in specific pathogen free (SPF) chickens, as the primary detection technology and is capable of detecting up to 90% of the HCP proteins present in the sample.

What makes IgY antibodies an attractive alternative to IgG is due in large part to the phylogenetic distance between avians and mammals. The avian IgY antibodies used in our CHO-Host Cell Protein kit recognize mammalian antigens as highly foreign, which produces an aggressive immune response that far exceeds those of other commercially available IgG HCP kits.

The Benefits of Using IgY vs IgG in Diagnostic Applications

Chicken immunoglobulin Y (IgY) is a highly conserved homolog of human immunoglobulin G (IgG) that has shown benefits and a favorable safety profile, primarily in animal models of human infectious diseases.

Compared to IgG, IgY antibodies:

• Are easy to produce
• Can be generated economically in large quantities
• Are more environmentally friendly
• Require less infrastructure investment by using egg-laying hens (1)

30 - 40-week-old hens are selected and immunized twice, two weeks apart. IgY antibodies are then isolated from egg yolks obtained from the HCP-immunized hens.

Q&A

What are host cell proteins?
Cell lines are commonly used in the production of recombinant therapeutic proteins and other drugs. Host-cell proteins are essential but non-desired proteins produced by bioproduction host cells (e.g., CHO cells, E. coli, yeast) used to produce monoclonal antibodies, recombinant proteins, and vaccines. Despite utilizing even the most sophisticated purification technology, some residual host cell proteins (HCPs) will remain in the intermediate drug product as process related impurities.

What are the impacts of improper impurity testing?
Removal of host-cell proteins constitutes a major part of contamination and impurity testing during biologics production and if not done properly can result in regulatory concerns or worse, potentially impacting patient safety and product efficacy due to adverse immunological reactions. Our CHO-Host Cell Protein ELISA kit detects up to 90% of the HCP proteins present in the sample.