The National Institute of Standards and Technology (NIST) has issued one of the world’s most intricate measurement standards: an exhaustively analyzed antibody protein that the biopharmaceutical industry will use to help ensure the quality of treatments across a widening range of health conditions, including cancers, autoimmune disorders and infectious diseases.
The standard is an antibody protein—consisting of more than 20,000 atoms—analyzed so thoroughly that the material can be used by organizations around the globe to verify and improve their analytical methods for quality control.
Donated by MedImmune, the global biologics research and development arm of AstraZeneca, and then characterized by NIST and collaborators, the new reference material (RM)—NIST RM 8671—is a monoclonal antibody, or mAb. This class of therapeutic compounds is produced in the lab by living cells, usually from mouse or hamster cell lines. Uniform in composition and structure, mAbs account for five of the 10 top-selling drugs and over $75 billion in annual sales worldwide. According to one estimate, about 300 monoclonal-antibody-based therapeutics are being evaluated for safety and effectiveness in clinical trials.
Antibodies work by binding to and inactivating proteins involved in disease pathways. mAbs also can act like guided missiles that precisely deliver therapeutic payloads of chemicals or radiation.
Chosen for development in consultation with industry, NIST RM 8671 is an important addition to the toolkits of biological drug manufacturers and their suppliers and regulators. It serves as a representative molecule that can be used to determine that methods for assessing product quality are working properly and to evaluate new methods or technologies.
It also provides an industry very mindful of intellectual property concerns with a standard benchmark for everyone, from aspiring startup to multinational firm to regulator.
As such, “it can serve as a common benchmark for future innovation,” explained NIST research chemist John Schiel, who led an international effort that explored and demonstrated uses of the reference mAb. “The material has many anticipated applications—in establishing industry-recognized best practices, for example—and we are hoping that there will be many future uses that we can’t predict from the current state of practice in biopharmaceutical research and production.”