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The Role of Measurement Science & Standards in Supporting Development of Biotherapeutics

Kolloquium der Abteilung 8

In this talk, I will provide an overview of the NIST Biomanufacturing Program, which was funded by a congressional initiative in 2012, to advance measurement science, technologies and standards that support the biopharmaceutical industry in developing new innovative protein therapeutics or biologics and accelerate the time to market for these products.  I will describe the three main areas of focus of the program, arrived at through extensive stakeholder engagement: (1) protein stability, (2) protein structure and (3) production cell science.  I will provide highlights of the measurement science, technologies and standards developed to date in each area. I will also describe more recent efforts that have expanded to include work with vaccines and emerging modalities such as cell and gene therapy products.