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A01=and Medicine
A01=Board on Health Sciences Policy
A01=Engineering
A01=Forum on Regenerative Medicine
A01=Health and Medicine Division
A01=National Academies of Sciences
Age Group_Uncategorized
Age Group_Uncategorized
Author_and Medicine
Author_Board on Health Sciences Policy
Author_Engineering
Author_Forum on Regenerative Medicine
Author_Health and Medicine Division
Author_National Academies of Sciences
automatic-update
B01=Ariel Markowitz-Shulman
B01=Joe Alper
B01=Meredith Hackmann
B01=Sarah H. Beachy
B01=Siobhan Addie
Category1=Non-Fiction
Category=M
COP=United States
Delivery_Delivery within 10-20 working days
Language_English
PA=Available
Price_€50 to €100
PS=Active
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Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop

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.

Table of Contents
  • Front Matter
  • 1 Introduction
  • 2 Transitioning from Discovery and Development to Manufacturing
  • 3 Identifying and Measuring Critical Quality Attributes
  • 4 Designing Technologies to Meet the Manufacturing Needs of New Regenerative Medicine Therapies
  • 5 Considerations for Improving and Regulating Regenerative Medicine Products
  • 6 Potential Next Steps for Supporting the Development, Manufacture, and Regulation of Regenerative Medicine Therapies
  • References
  • Appendix A: Workshop Agenda
  • Appendix B: Speaker Biographical Sketches
  • Appendix C: Statement of Task
  • Appendix D: Registered Attendees
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€62.99
A01=and MedicineA01=Board on Health Sciences PolicyA01=EngineeringA01=Forum on Regenerative MedicineA01=Health and Medicine DivisionA01=National Academies of SciencesAge Group_UncategorizedAuthor_and MedicineAuthor_Board on Health Sciences PolicyAuthor_EngineeringAuthor_Forum on Regenerative MedicineAuthor_Health and Medicine DivisionAuthor_National Academies of Sciencesautomatic-updateB01=Ariel Markowitz-ShulmanB01=Joe AlperB01=Meredith HackmannB01=Sarah H. BeachyB01=Siobhan AddieCategory1=Non-FictionCategory=MCOP=United StatesDelivery_Delivery within 10-20 working daysLanguage_EnglishPA=AvailablePrice_€50 to €100PS=Activesoftlaunch
Delivery/Collection within 10-20 working days
Product Details
  • Dimensions: 152 x 229mm
  • Publication Date: 29 Jan 2018
  • Publisher: National Academies Press
  • Publication City/Country: United States
  • Language: English
  • ISBN13: 9780309466479

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