New Cell Lines Produce NIST Monoclonal Antibody for Improved Manufacturing of Biologic Drugs

When the National Institute of Standards and Technology (NIST) issued the world’s first standardized monoclonal antibody (mAb) in July 2016, the exhaustively analyzed protein known as NISTmAb (NIST Reference Material 8671) was intended as a valuable tool for biopharmaceutical companies. Its purpose: to help ensure the quality of measurement techniques used in the development and manufacture of biologic drug therapies for a wide range of health conditions, including cancers, autoimmune disorders and infectious diseases. Although the molecule has been precisely characterized, the current proprietary method for its production has not.