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Regenerative Medicine and Advanced Therapies

Summary

Regenerative medicine and 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.

This program is designed to assist the nascent and promising regenerative medicine industry to meet their measurement assurance and regulatory challenges. 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. Our effort aims to improve the confidence in cell measurements needed for translation and commercialization of advanced therapies, including cell therapy, gene therapy, and tissue engineering 

Description

Reg. Med. Image
Our laboratory programs include quantitative genomic and cell measurements, live cell imaging, tissue engineering,  and quantitative flow cytometry for cells and gene-modified cells as well as measurement assurance strategies for advanced therapeutic products. Much of our laboratory programs are conducted in collaborations with industry and federal agency partners and leverage NIST expertise in measurement science to address immediate and broad industry needs. We coordinate with key stakeholders to address cell measurement challenges and development of standards. 
 
Measurement Assurance 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 with key stakeholders to develop Standard Reference Materials and Documentary Standards for regenerative medicine and advanced therapy products, and is leading and contributing to various Standards Development Organizations including ISO/TC 276 and ASTM F04. In addition, NIST administers the US TAG to ISO/TC276 Biotechnology as a means to coordinate national and international standards activities for existing and emerging biotechnology sectors, including regenerative medicine and advanced therapies. In particular, WG3 Analytical Methods is developing standards to enable confident measurements of cells and nucleic acids, and WG4 Bioprocessing is developing a suite of standards aimed to improve the consistency of manufacturing processes for cellular therapeutic products.

 

  • Click here to learn more about  ISO/TC 276  resources
  • Click here for general information about ASTM F04 
  • Click here for general information about creating standards in the field of regenerative medicine
  • Click here for an overview of standards development principles
Stakeholder Engagement – NIST works with industry, academia, and other agencies to identify and develop measurement solutions.

 

 
 

 

Created September 6, 2016, Updated October 9, 2019