Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies
Proceedings of a Workshop
by National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Regenerative Medicine, Sarah H. Beachy, Joe Alper, Meredith Hackmann, Siobhan Addie, Ariel Markowitz-Shulman
Description
On June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC, titled Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies in order to examine and discuss the challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop was to learn from existing examples of the manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes. The workshop also addressed the challenges of designing and adhering to standards as a way of helping those who are working to scale up processes and techniques from a research laboratory to the manufacturing environment. This publication summarizes the presentations and discussions from the workshop.
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https://www.nap.edu/24913
Copyright Information
Copyright year 2017
National Academies Press
The National Academies Press (NAP) publish the reports of the National Academies of Sciences, Engineering and Medicine. They published more than 200 books a year on a wide range of topics.
View all titlesBibliographic Information
- Publisher National Academies Press
- Publication Date July 2018
- Orginal LanguageEnglish
- ISBN/Identifier 9780309466479 / 0309466474
- Publication Country or regionUnited States
- FormatPaperback
- Primary Price 42 USD
- Pages124
- ReadershipProfessional and scholarly
- Publish StatusPublished
- Copyright Year2017
- Dimensions9 X 6 inches
- Reference Code101722624913
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