CHO-Host Cell Protein ELISA Kit Product Information
- Storage: All HCP kit reagents 2 °C to 8 °C
- Target Expression System: CHO
- Species Group: Mammalian
- Species: Chinese hamster
- HCP kit assay format: 96 Well Plate
- Time to HCP testing result: ~3 hours
- LOD: 0.1 ng/mL
- LLOQ: 2 ng/mL
- Minimum Diluent: 1:2
- Antibody Coverage: 90%
- HCP ELISA kit 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 (HCP) kits, our CHO-HCP ELISA kit leverages the avian IgY antibody, specifically, those found in specific pathogen free (SPF) chickens, as the primary HCP detection technology and is capable of detecting up to 90% of the HCP proteins present in the sample.
What makes IgY antibodies in Charles River's HCP kit 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 testing kits.
Phylogenetic Distance
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)
Chicken Immunization Strategy
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.
Partnership and Development Opportunities for HCP Kits
Are you tired of running into coverage GAPs? Our CHO-HCP ELISA kit is only the first of many cell lines we have finished development work on. However, we are actively seeking partners to expand our patented technology to additional cell lines in the future. The only question remaining is, “what cell line do you need?”
Custom HCP Testing Development Services
We have more than 30 years of experience in impurity testing and have been entrusted by our clients to develop more than 150 project-specific and platform host-cell protein assays for a wide variety of expression systems. Whether you’re in early phase development or late phase clinical trials, our custom HCP-GAPex℠ assay development services will enable you to close the coverage GAP in your downstream processing throughout the entire lifecycle of your product. See our services
Our Expression System Experience
- Mammalian: CHO, HEK293, PER.C6®, Vero, MDCK
- Bacterial: E. coli; B. subtilis
- Yeast: S. cerevisiae, P. pastoris; K. lactis
- Insect: SF+, Baculovirus
- Plant: Tobacco
FAQs for CHO-HCP ELISA Kits
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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.
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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.