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Benchmarks for Biologic Drugs

Protein-based biologic drugs, which are increasingly used to treat cancers, autoimmune disorders and infectious diseases, are hard to produce, store and deliver reliably. Better measurement tools developed by NIST drive innovation and lower costs associated with these drugs.

 

NISTmAb crystal structure

NIST partnered with dozens of biopharmaceutical companies to develop a representative material to benchmark the different tests each company uses when developing and manufacturing their proprietary drugs. This material comes with a comprehensive profile of physical and chemical attributes to which companies can check their own techniques. This material helps in the development, quality control and testing of biological drugs.

The global therapeutic antibody market was over $100 billion in 2016, and growing. Even though multiple drug companies are pursuing monoclonal antibody (mAb)-based therapeutics, the differences in the tests from company to company make it difficult to know if the manufactured drug was made correctly. As a result, industry representatives asked NIST to develop an mAb reference material, NISTmAb.

NIST used donated material received as part of a multi-year agreement with MedImmune. NIST worked with  more than 15 companies to characterize the material, resulting in a three volume reference set that thoroughly details the progress made by the research team within the broader context of mAb science and future characterization needs.

Questions? Contact inquiries [at] nist.gov (subject: Industry%20Impacts%3A%20Biopharmaceuticals) (NIST Inquiries).