HCP Assay Development
The presence of residual host cell proteins (HCPs) is a potential safety risk in any biopharmaceutical product. With over 30 years of combined experience, our team of host cell protein experts assists clients in the development of a downstream process with the use of effective assays to determine both the concentration of the product and the quantity and concentration of host cell proteins present. The assays used accurately monitor changes in the product concentration and the removal of host cell proteins after purification.
Charles River's HCP-GAPex℠ service is the first holistic approach to host cell protein assay development. Combining tools from proteomics, bioinformatics, protein synthesis and immunology, the service minimizes black box elements, provides targeted enhancement of coverage and maximizes the performance of HCP assays.
Early Phase Assays
In the early process development phase as well as in early clinical phases, generic HCP assays are normally acceptable. Charles River supports these phases with:
- Assays for E. coli and CHO-derived products - developed and validated on a generic sample matrix and useful for a general investigation into HCP burden
- Kits on any kind of cell systems adapted for a client matrix
Clinical Phase III Assays
Once a biopharmaceutical is used in clinical phase III studies, a validated, product-specific HCP assay is normally required. Charles River is an expert in the field of customized HCP assay development and offers a fully integrated approach for this, including:
- Development of customized assays on different cell matrices using either ILA or ELISA
- Inoculation of antigens for antiserum production and then purification of antibodies for use in client-specific assays
- Validation of assays and routine testing services