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NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.
The National Institute of Standards and Technology (NIST) has issued a monoclonal antibody (mAb) reference material (RM), NIST RM 8671. Donated by MedImmune, the global biologics research and development arm of AstraZeneca, and then characterized by NIST and collaborators, the reference mAb 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 can serve as a common benchmark for future innovation,” explained NIST research chemist John Schiel, in a July 28, 2016 press release. “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.” Schiel led an international effort that explored and demonstrated uses of the reference mAb. Industry experts have indicated that a universally available public mAb, characterized and distributed by NIST, will allow better assessment of existing analytical methods and potentially faster adoption of new technologies.
Each vial of NIST RM 8671 will contain 800 microliters of the NISTmAb at a concentration of 10 milligrams per milliliter, and will be shipped in cryovials packaged in dry ice. The standard comes with the results of NIST measurements that provide a thorough profile of the standard protein, Schiel said, providing details on size, concentration, composition, structure, purity, stability, and other attributes.
The new standard can be used as a “universal system suitability test” for many of the assays and test methods used to assure the quality of mAbs, said Kurt Brorson, a research biologist in the Office of Biotechnology Products at FDA, in the press release. “The biotech industry can more efficiently cross-validate (measurement) methods at different sites or more efficiently develop platform analytics for related molecules,” he explained.
“The NISTmAb should help in answering a simple, yet critical, question that can consume a disproportionate amount of time when deviations arise with testing; is it the sample or the method that is varying?” said Michael Tarlov, chief of NIST’s Biomolecular Measurement Division and leader of the NIST-wide Biomanufacturing Program, in the press release.