Development of HCP ELISA kit specific to your expression system
Host Cell Proteins (HCP) are heterogeneous mixture of impurities found in recombinant biotherapeutics. The specific characteristics of HCP depend on the type and strain of cells used (E.coli, CHO, insect cells, …), on the intra or extracellular secretion of the recombinant protein as well as on the purification process used.
According to the fact that HCP contamination of the final drug product can lead to immunogenic or toxic reactions in patients, there are strictly regulatory guidelines that defines the limits of HCP concentration in the drug product. As a consequence, it is necessary for biopharmaceuticals companies to implement reliable methods to quantify HCP and to prove the drug product purity and safety.
ELISA test has become the gold standard method for HCP measurements. They are based on polyclonal antibodies directed against the HCP issued from the original cell line used in the expression platform. Several generic HCP ELISA assays are commercially available for the most commonly expression systems, i.e. expressions platform using bacterial or mammalian cells. However regulatory agencies suggest to biopharmaceuticals to develop “process specific” ELISA tests in order to obtain highly specific and sensitive HCP assays.
According to its high expertise in ELISA test development and manufacture, IDBiotech offers custom HCP ELISA development.
Our services include:
– Strategy for polyclonal antisera production: choice of the host species, immunization protocol for optimal HCP coverage
– Antibody coverage evaluation: 1D Western blotting analysis
– Purification: purification of IgG by affinity on protein A/G, purification of antibodies by affinity on antigen
– Labeling: production of detection reagent by labeling of IgG or antibodies to biotin or HRP
ELISA development and validation
– Development of HCP ELISA in order to fit with the customer’s requirements
– Optimization of the HCP ELISA test
– Design of the ELISA test on a ready-to-use ELISA kit
– Validation of the HCP ELISA according to customer’s requirements and ICH guidelines
– Stability studies of the kits components
– Manufacturing of ready-to-use ELISA kits
– Quality control of the ELISA kits during the shelf life of the batch
– Optimization and/or adaptation of existing HCP ELISA test the customer’s requirements
– Routine testing of customer’s samples
– Assay transfer and training on site