Développement à façon de kit ELISA HCP spécifique de votre système d’expression
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 and services.
Antibody Production and Characterization
– Strategy for polyclonal antisera production: choice of the host species, sample selection according to your DSP, immunization protocol for optimal HCP coverage
– Production of antibodies in bulk conditions in different animal species
– Determination of antibody coverage using 2D Western-Blotting technology
– Purification and labelling to biotin and/or HRP of the anti HCP antibodies
ELISA development and validation
– Development of HCP ELISA in order to fit with the customer’s needs and to the regulatory agency’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
– Selection of the generic ELISA kit that best fit to your DSP and product
– Determination of the antibody coverage of the generic ELISA kit you use by 2D Western Blotting
– 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