Advanced therapies are demonstrating promising clinical efficacy and could change the paradigm for treating a wide range of diseases and injuries. Clinical translation of this broad class of new therapeutics requires better defined and characterized products and more robust, reliable, and cost-effective manufacturing processes.
NIST contributes to this effort by 1) developing measurement solutions, 2) serving as a neutral ground for the discussion of underpinning measurements and other manufacturing needs, and 3) leading and contributing to the development of standards. These efforts work collectively to to facilitate advances in R&D and manufacturing.
Development of a measurement infrastructure, including enabling tools, methods and protocols, bioinformatics and modeling tools as well as documentary standards and reference materials.
The challenges in characterization of advanced therapy products may be largely addressed with systematic approaches for assessing sources of uncertainty and improving confidence in key measurements. NIST is developing strategies to ensure measurement confidence and discusses them in terms of how they can be applied to characterization of advanced therapy products.
Standards are critical in the development and commercialization of new technologies and facilitate national and international commerce. Standards also have an important role to ensure product consistency and facilitate regulatory approval. NIST is working to develop Standard Reference Materials and Documentary Standards with key stakeholders to develop standards for this field, including leading and contributing to various Standards Development Organizations (SDO) including ASTMi and ISO.
NIST works with industry, academia, and other agencies to identify and develop measurement solutions.
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