![]() Therapies composed of monoclonal antibodies are the most common type of biopharmaceutical.Īny change in the higher order structure of a protein can prevent it from functioning properly: Biopharmaceutical proteins that deviate from their designed shape will not hit their intended therapeutic targets. ![]() Global sales of biopharmaceuticals reached nearly $153 billion dollars in 2017. The 2D NMR method for mAbs, originally demonstrated at NIST, gives developers, manufacturers, and regulators a robust way to assess this critical characteristic linked to drug quality and performance.īiopharmaceuticals-large, complex protein molecules- are used to treat serious and life-threatening conditions such as cancer, autoimmune disorders, infectious diseases, and other illnesses. Researchers at the National Institute of Standards and Technology (NIST) recently completed a large international study* that establishes two-dimensional nuclear magnetic resonance (2D NMR) as a reliable way to compare the three-dimensional structures of monoclonal antibody biopharmaceuticals (mAbs), the largest and fastest growing class of therapeutics.īecause a mAb’s three-dimensional shape, a lso known as its higher order structure, is linked to its function, it is considered a “critical quality attribute:” a key property used to assess biopharmaceutical product quality. ![]() The labels mark the fragments Fab and Fc that were used in a novel NIST two-dimensional NMR fingerprinting method to measure the structural configuration of the entire antibody. A schematic showing the NISTmAb monoclonal antibody, an immunoglobulin G molecule developed by NIST as a reference material. ![]()
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