The growing need for standards in the rapidly evolving world of biopharmaceuticals and cell and gene therapies (CGTs) is giving rise to an expanding array of collaborative initiatives, products, and processes, many of which are flowing through the U.S. National Institute of Standards and Technology (NIST).
From the NISTmAb – a key purpose of which is to improve the quality of measurement techniques for monoclonal antibody products – to new cell counting technologies, to providing support and funding for the National Institute for Innovation in Manufacturing of Biologicals (NIIMBL), NIST is making a significant commitment to assisting industry in advancing biopharmaceutical/CGT development, manufacturing, and analysis.
A salient feature of NIST’s efforts in the biologics arena is the institute’s involvement with numerous industry partners, academia, consortia, and other government agencies – drawing on a large network of stakeholders who contribute to and benefit from their shared efforts in the pre-competitive space.
NIST Playing A Strong Role In Creating Standards For CGTs
Exploring the coordinated efforts NIST is engaged with to “develop a robust standards infrastructure” for the advanced therapies at a PDA CGT conference in Bethesda, Maryland in October 2018, NIST Biosystems and Biomaterials Division Chief Sheng Lin-Gibson explained that “NIST is not a regulatory agency.” Instead, the organization was founded in 1901 to assist industry and commerce by establishing and maintaining standards, such as weights and measures, upon which industry and commerce depend.
After introducing NIST, she reviewed: ● the role and development of CGT-related standards – the different types that come into play, who is developing them, and how they are being coordinated, and ● the standards efforts now underway in the areas of cell counting, cell characterization, connectivity, reference materials, genome editing, flow cytometry, and measuring assurance. [See IPQ January 31, 2018 for a mid-2017 review of NIST’s growing involvement in the CGT ecosystem by Lin-Gibson’s predecessor, Anne Plant, who is now a NIST Fellow.]