Host Cell Protein (HCP) monitoring during biological drug manufacturing is crucial. This is required to reduce the adverse side effects that the (high) abundance of host cell protein-derived impurities in the final drug substance may have when administered to human bodies, or when HCP affect the drug product itself. The particular HCP profile of a drug production is unique and depends on particular cell culturing conditions and the quality of manufacturing and downstream processes.
While traditional generic HCP assays provide just a single antibody that must work for all processes, the enhanced generic 360-HCP ELISA provides four kits, each using a different set of anti-HCP antibodies.
Thus, the enhanced generic 360-HCP approach results in host cell protein (HCP) assays that are demonstrably superior to traditional generic HCP assays by minimizing well-known limitations. This includes the possibility that single-kit anti-HCP antibodies might not comprehensively detect HCPs present in a manufacturer's sample.
If you want to learn more about BioGenes' service diversity to enable monitoring of HCP impurities along the various phases of drug manufacturing and market authorization, have a look at our webinar.
Take advantage of BioGenes' Generic 360-HCP approach now and start to monitor your HCPs with the Starter Set from our webshop!
The manufacturing of each enhanced generic HCP ELISA kit type involves the following steps:
- Immunization of individuals using particular antigen material
- Isolation of polyclonal antibodies and purification
- Manufacturing of ready-to-use ELISA kits
The antibodies of each individual kit type will display specific reactivity towards a subset of the total protein profile and will show weak or no reactivity towards other proteins of given strain/cell line. The proportion of proteins being recognized compared to the total protein is termed coverage.
Each drug manufacturing process results in a particular HCP profile. To achieve optimal HCP monitoring, a testing for best fit should be applied. As depicted, the antibody panel of the upper kit covers a broader range of HCPs in the exemplary project sample compared to the kit on the bottom. Thus, the upper kit would be the better choice to achieve monitoring of HCP reduction due to better overall coverage. For the identification of the generic 360 HCP ELISA kit with the best fit, BioGenes recommends to apply testing for
Critical HCP ELISA performance criteria
- HCP coverage
- Sufficient HCP log-reduction
- ELISA accuracy
- Sample dilution linearity
- Uses Streptavidin-POD conjugate for detection of biotin-labeled antibodies for reproducible results
- Two-step protocol reduces unspecific bindings
- Includes Undiluted standard for higher product stability and flexibility
- Automated plate washing possible
- Test all 4 kits at once using BioGenes' Starter Set option
According to the Annex XIV of the Regulation (EC) No 1907/2006 of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), Triton™ X-100 (contains 4-(1,1,3,3-Tetra-methylbutyl)phenol, ethoxylated) will be replaced by TWEEN®20 (Polysorbate 20) in all our ELISA kit components by January 1st, 2021.
To read the statement of BioGenes' Management , please download this document.