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000 camIi
001 2210080853191
003 OCoLC
005 20190103135258
006 m d
007 cr un|||||||||
008 180202s2017 dcua ob 100 0 eng
016 a1017207532DNLM
020 a9780309466486q(electronic bk.)
020 a0309466482q(electronic bk.)
020 z9780309466479
020 z0309466474
024 a10.17226/249132doi
035 a1672347b(NT)
035 a(OCoLC)1019666357
040 aNLMbengerdacNLMdMMUdNdCNCGMdMERUCdEBLCPdOCLCOdNd221008
050 aQH499b.N38 2017
072 aSCIx0560002bisacsh
082 a571.8/89223
111 aNavigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies (Workshop)d(2017 :cWashington, D.C.)
245 00 aNavigating the manufacturing process and ensuring the quality of regenerative medicine therapies :bproceedings of a workshop /cAriel Markowitz-Shulman, Sioghan Addie, Meredith Hackmann, Joe Alper, and Sarah H. Beachy, rapporteurs; Forum on Regenerative Medicine, Board on Health Sciences Policy, Health and Medicine Division, The National Academies of Sciences, Engineering, Medicine.
260 aWashington, District of Columbia :bThe National Academies Press,c[2017]
300 a1 online resource (1 PDF file (xx, 104 pages)) :billustrations.
336 atextbtxt2rdacontent
337 acomputerbc2rdamedia
338 aonline resourcebcr2rdacarrier
504 aIncludes bibliographical references.
520 aOn 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.
536 aThis project was supported by contracts between the National Academy of Sciences and Akron Biotech (unnumbered contract); Alliance for Regenerative Medicine (unnumbered contract); The ALS Association (unnumbered contract); American Society of Gene & Cell Therapy (unnumbered contract); Burroughs Wellcome Fund (Grant #1015949); California Institute for Regenerative Medicine (unnumbered contract); Centre for Commercialization of Regenerative Medicine (unnumbered contract); Christopher & Dana Reeve Foundation (unnumbered contract); Department of Veterans Affairs (Contract No. VA268-16-C-0051); Foundation Fighting Blindness (unnumbered contract); GE Healthcare (unnumbered contract); GlaxoSmithKline (Grant ID: 015948); International Society for Stem Cell Research (unnumbered contract); Johnson & Johnson (unnumbered contract); Juno Therapeutics, Inc. (unnumbered contract); The Michael J. Fox Foundation for Parkinson's Research (unnumbered contract); National Institute of Standards and Technology (unnumbered contract); National Institutes of Health (Contract No. HHSN263201200074I, Order No. HHSN23600075: National Heart, Lung, and Blood Institute; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Biomedical Imaging and Bioengineering; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; and National Institute of Neurological Disorders and Stroke); The New York Stem Cell Foundation (unnumbered contract); Parkinson's Disease Foundation (unnumbered contract); Pfizer Inc. (unnumbered contract); Takeda Pharmaceuticals U.S.A., Inc. (Contract #65317); United Therapeutics Corporation (unnumbered contract); and U.S. Food and Drug Administration (Grant #1R13FD005355-01). Any opinions, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
588 aOnline resource; title from PDF title page (EBSCO, viewed March 7, 2018)
590 aMaster record variable field(s) change: 050, 072, 082, 650
650 aRegenerative medicinevCongresses.
650 aSCIENCE / Life Sciences / Anatomy & Physiology.2bisacsh
655 aElectronic books.
700 aAddie, Siobhan,erapporteur.
700 aHackmann, Meredith,erapporteur.
700 aAlper, Joe,erapporteur.
700 aBeachy, Sarah H.,erapporteur.
700 aMarkowitz-Shulman, Ariel,erapporteur.
710 aNational Academies of Sciences, Engineering, and Medicine (U.S.).bForum on Regenerative Medicine.
710 aNational Academies of Sciences, Engineering, and Medicine (U.S.).bBoard on Health Sciences Policy.
710 aNational Academies of Sciences, Engineering, and Medicine (U.S.).bHealth and Medicine Division.
856 3EBSCOhostuhttp://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=1672347
938 aEBSCOhostbEBSCn1672347
938 aEBL - Ebook LibrarybEBLBnEBL5215362
994 a92bN
Navigating the manufacturing process and ensuring the quality of regenerative medicine therapies :proceedings of a workshop /Ariel Markowitz-Shulman, Sioghan Addie, Meredith Hackmann, Joe Alper, and Sarah H. Beachy, rapporteurs; Forum on Regenerative Medicine, Board on Health Sciences Policy, Health and Medicine Division, The National Academies of Sciences, Engineering, Medicine
Material type
전자책
Title
Navigating the manufacturing process and ensuring the quality of regenerative medicine therapies :proceedings of a workshop /Ariel Markowitz-Shulman, Sioghan Addie, Meredith Hackmann, Joe Alper, and Sarah H. Beachy, rapporteurs; Forum on Regenerative Medicine, Board on Health Sciences Policy, Health and Medicine Division, The National Academies of Sciences, Engineering, Medicine
Author's Name
Addie Siobhan rapporteur Hackmann Meredith rapporteur Alper Joe rapporteur Beachy Sarah H. rapporteur Markowitz-Shulman Ariel rapporteur
Publication
Washington, District of Columbia : The National Academies Press [2017]
Physical Description
1 online resource (1 PDF file (xx, 104 pages)) : illustrations.
Keyword
Includes bibliographical references. / 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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