Custom Host Cell Protein (HCP) ELISA Development
BioGenes has a twenty-year proven track record in the development of highly sensitive Host Cell Protein ELISAs. During this time, we have developed more than 200 HCP ELISAs, which are both multi-product/platform and specific. We are familiar with the requirements of the regulatory bodies, as many of our HCP ELISAs have been used for late stage clinical trials and for drug approvals by the EMA and FDA.
| Multi-product HCP ELISAs | Specific HCP ELISAs | |
| HCP population is cell line-specific | Yes | Yes |
| Assay is used for a single manufacturing process | No | Yes |
| Assay is used for several products | Yes | No |
General features:
- Multi-product/platform HCP ELISAs are developed for our clients' production cell lines
- They are far more sensitive and specific than an off-the-shelf generic HCP ELISA
- Specific HCP ELISAs are exclusively developed for a single manufacturing process
Our services include:
- Project design and proactive project management in close cooperation with the customer
- In-house development of antibodies (immunization of rabbits, goats, sheep)
- Characterization of antibodies (2D Western blot for HCP coverage determination, performance tests in a preliminary ELISA set-up)
- Development of HCP ELISAs in buffer solution and working matrices
- Qualification/pre-validation of HCP assays according to customers’ requirements and ICH guidelines (ICH Q2B)
- Production of complete ready to use kits or single assay components
- Detailed documentation and reporting
- Technology transfer to the customer – SOPs and training of the staff
