RESEARCHING AND DEVELOPING OF ETANERCEPT FOR TREATMENT OF RHEUMATOID ATHRITIS USING RECOMBINANT PROTEIN TECHNOLOGY.

Abstract

              Rheumatoid Athritis (RA) is an auto immunity disease that relates to the Tumour necrosis factor (TNF). Recent studies concerning how to treat RA are focusing on blocking the TNF signaling pathway. One of TNF blocking agent that had been approved by FDA is Etanercept (a fusion protein containing TNF receptor and the human immunoglobulin). Etanercept has been producing by recombinant DNA technology using CHO cell line. This project has been successfully done by establishing the master cell bank of CHO cells and the culturing process that could be able to produce approximately 2 g Etanercept per liter of cell broth; developing and validating the downstream process purify of Etenercept with the purity of over 94%, recovery rate of over 70%. The purified protein has the biological activity and the biosimilarity equal to the innovator drug (Enbrel).