Relevant Publications & Printables

Printable Fact Sheets and Brochures

  • Benefits of Standards Fact SheetHighlights ways that standards development can help overcome current challenges and benefit stakeholders throughout the regenerative medicine community

  • Guide to Standards TerminologyStandards terminology has a great deal of nuance that can be disorienting for those new to the topic. Learn more about the key terms and concepts.

  • Strengthening Standards Development Process Brochure Details how SCB supports the standards advancement process and how stakeholders can get involved

  • Documentary Standards Brochure Describes the benefits of documentary standards, the organizations who develop them, how they are developed, and how SCB supports the process; also includes three case studies of documentary standards development related to regenerative medicine

  • Reference Materials Brochure Describes the benefits of reference materials, the organizations who develop them, how they are developed, and how SCB supports the process; also includes three case studies of reference materials development related to regenerative medicine

  • ASTM Regenerative Medicine Standards Development Efforts Fact SheetProvides a high-level overview of ASTM International, its technical committees, and its currently available and in-development standards related to cell therapy, gene therapy, and tissue engineering

  • ISO Regenerative Medicine Standards Development Efforts Fact SheetProvides a high-level overview of ISO, its technical committees, and its currently available and in-development standards related to cell therapy, gene therapy, and tissue engineering

  • About SCB Fact Sheet Provides an overview of SCB’s efforts and how to get involved

Publications

FDA and NIST collaboration on standards development activities supporting innovation and translation of regenerative medicine products

Published in: Cytotherapy, June 2018

Authors: Judith A. Arcidiacono, Steven R. Bauer, David S. Kaplan, Claire M. Allocca, Sumona Sarkar, Sheng Lin-Gibson


summary of the nist and u.s. fda cell counting workshop: sharing practices in cell counting measurements

Published in: Cytotherapy, June 2018

Authors: Sheng Lin-Gibson, Sumona Sarkar, John Elliot


The Regenerative Medicine Standards Landscape

Published: February 2018 (current version updated Spring 2019)

Authors: Nexight Group and SCB

 


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Points to Consider for Cell Manufacturing Equipment and Components

Published: Cell & Gene Therapy Insights, December 2017

Authors: Sheng Lin-Gibson, Brian Hanrahan, Sandro Matosevic, Aletta Schnitzler, Jiwen Zhang, & Claudia Zylberberg