ELISA for Host Cell Protein detection
A HCP immunoassay is a specialized assay that is against all proteins of the cell line used to manufacture the therapeutic biopharmaceutical. The species is selected on the basis of its advantages for the experimental set-up. CHO or pichia pastoris cells for example are harder to cultivation but the product benefits from post-translational patterns similar to mammalian (and therefore human) patterns. antibodies-online offers customized HCP immunoassay production tailored for your project. Get in touch with our experts:
HCP ELISA for Process Monitoring
The antibody for the HCP ELISA reagent is generated in order to achieve a high coverage of host cell proteins, ideally it targets all proteins. Main purpose of HCP ELISA kits is to monitor in-process consistency in the purification of the molecule of interest. A HCP immunoassay against all proteins of the cell line is used to manufacture the therapeutic biopharmaceutical. The antibody for the HCP ELISA reagent is generated in order to achieve a high coverage of host cell proteins, ideally it targets all proteins.
Generic HCP ELISA Kits
Generic ELISA kits are useful in both process development and process validation. Commercially available generic HCP ELISA kits are broadly used for monitoring of HCP decrease in biologicals during pre- and early clinical phases. Using these kits in the earliest phase of product development can provide relevant and specific data directing process improvement and decreasing the levels of HCP contamination.
Process Specific HCP ELISA Kits
Regulations for biopharmaceuticals require HCPs be reduced to the lowest levels possible. ELISA kits are the go-to method to achieve reliable and consistent monitoring of HCP. EMA and FDA, two major regulatory bodies, have released a set of guidelines to regulate the control of HCPs during the production process (as of June 2018).
Guidelines key points
- Aim for high sensitive methodologies
- Routine tests for residual HCPs required
- Final amount of HCP in drug bulk is lower than (<1-100 ppm)
For drug approval, the development of a process specific ELISA is generally unavoidable. Only a specific HCP ELISA can meet the requirements, such as providing reliability regarding performance and availability. Moreover, the selection of a specific development ensures you a sufficient amount of antibodies for the complete drug production phase. Specific HCP ELISAs are exclusively developed for a single manufacturing process. This is why they show higher sensitivivity and specificity in comparison to off-the-shelf generic ones. Consequently the procentual HCP coverage ist higher as well. In quality control applications, subject to thorough validation and qualification by each laboratory, these kits may also be useful for lot release testing. antibodies-online offers customized HCP immunoassay production tailored for your project. Get in touch with our experts: