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.