Custom Cell Protein (HCP)

Tamilnadu Test House are experts in the development of high sensitive Host Cell Protein (HCP) assays for therapeutic proteins and antibodies. As per the current Indian regulatory guidelines, biopharmaceutical companies should develop product specific HCP assays to evaluate the therapeutic protein purity.

We initially evaluate the feasibility of our generic HCP assay kit for client requirements. Multiproduct Host Cell Protein assays are suitable for bio-pharma manufacturers who use a proprietary production in bacteria and cell line for their products. The assays are generated against host organism specific HCP populations that are prepared from optimized and validated cultivation and fermentation. We also adapt client’s processes for developing both product specific and generic HCP assays. Tamilnadu Test House scientists have developed HCP assays for products derived from E.coli and in addition we are involved in developing CHO, NS/0.

Our HCP package includes:

• Project design and communication with customer
• In-house antibody development (Cascade immunization)
• Characterization by 1D, 2D analysis, ELISA and Western Blot
• Development of HCP assays in buffer solution and sample matrices.
• Validation of HCP assay according to customer’s requirements and ICH guidelines (ICH Q2B)
• Manufacturing of complete kits or assay reagents.
• Technology transfer to the customer and training.