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

Abstract

Rheumatoid Arthritis (RA) is an auto immunity disease that relates to the tumour necrosis factor (TNF). Recent studies concerning how to treat RA have focused on blocking the TNF signaling pathway. One of the TNF blocking agents that have been approved by FDA is Etanercept (a fusion protein containing TNF receptor and the human immunoglobulin). Etanercept has been produced by recombinant protein 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, develop and validate 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 control drug (Enbrel).