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Volumn 82, Issue 3, 2007, Pages 320-324

Infrastructure development for human cell therapy translation

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT DNA;

EID: 34547890682     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/sj.clpt.6100288     Document Type: Review
Times cited : (47)

References (19)
  • 1
    • 0024995405 scopus 로고
    • Standards for bone marrow processing laboratories
    • Rowley, S.D. & Davis, J.M. Standards for bone marrow processing laboratories. Transfusion 30, 571-572 (1990).
    • (1990) Transfusion , vol.30 , pp. 571-572
    • Rowley, S.D.1    Davis, J.M.2
  • 2
    • 0027056866 scopus 로고
    • Quality assurance and standards in hematopoietic progenitor processing
    • Bennett, S.T., Johnson, N.L. & Lasky, L.C. Quality assurance and standards in hematopoietic progenitor processing. J. Clin. Apheresis 7, 138-144 (1992).
    • (1992) J. Clin. Apheresis , vol.7 , pp. 138-144
    • Bennett, S.T.1    Johnson, N.L.2    Lasky, L.C.3
  • 5
    • 34547894425 scopus 로고    scopus 로고
    • FDA
    • FDA. Tissue related documents 〈http://www.fda.gov.cber/ tissue/docs.htm〉 (2007).
    • (2007) Tissue related documents
  • 7
    • 84881572001 scopus 로고    scopus 로고
    • FDA
    • FDA. Guidance documents 〈http://www.fda.gov/opacom/ morechoices/industry/guidedc.htm〉.
    • Guidance documents
  • 9
    • 84876041033 scopus 로고    scopus 로고
    • Regulatory pathways: What regulations apply 〈http://www.fda.gov/cber/tissue/hctpreg012407rs.htm〉
    • San Antonio, TX
    • Solomon, R. Regulatory pathways: what regulations apply 〈http://www.fda.gov/cber/tissue/hctpreg012407rs.htm〉 3rd Annual FDA and the Changing Paradigm for HCT/P Regulation, San Antonio, TX (2007).
    • (2007) 3rd Annual FDA and the Changing Paradigm for HCT/P Regulation
    • Solomon, R.1
  • 10
    • 34547908322 scopus 로고    scopus 로고
    • FDA
    • FDA. CBER Homepage 〈http://www.fda.gov/cber/index.html〉.
    • CBER Homepage
  • 11
    • 34547906873 scopus 로고    scopus 로고
    • FDA
    • FDA. CDER Homepage 〈http://www.fda.gov/cder/index.html〉.
    • CDER Homepage
  • 12
    • 34547901220 scopus 로고    scopus 로고
    • FDA, and, CFRPart=210&showFR=1〉〈http://www.accessdata.fda.gov/script s/ cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1
    • FDA. 21 Code of Federal Regulations Parts 210 and 211 〈http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm? CFRPart=210&showFR=1〉 and 〈http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1〉 (2006).
    • (2006) 21 Code of Federal Regulations Parts 210 and 211
  • 13
    • 34547864422 scopus 로고    scopus 로고
    • FDA. Code of Federal Regulations Title 21, Food and Drugs 2006
    • FDA. Code of Federal Regulations Title 21 - Food and Drugs 〈http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch. cfm〉 (2006).
  • 15
    • 34547884838 scopus 로고    scopus 로고
    • Facility design and CGMP considerations for cell therapy products
    • Crim, J. Facility design and CGMP considerations for cell therapy products. in ISCT 6th Ann. Symp. 〈http://www.fda.gov/cber/ genetherapy/isct092506jcr.htm〉 (2006).
    • (2006) ISCT 6th Ann. Symp
    • Crim, J.1
  • 16
    • 0034107531 scopus 로고    scopus 로고
    • and Drug Administration's proposed approach to regulation of hematopoietic stem/progenitor cell products for therapeutic use
    • Harvath, L. Food and Drug Administration's proposed approach to regulation of hematopoietic stem/progenitor cell products for therapeutic use. Transfus. Med. Rev. 14, 104-111 (2000).
    • (2000) Transfus. Med. Rev , vol.14 , pp. 104-111
    • Harvath, L.F.1
  • 18
    • 0033936102 scopus 로고    scopus 로고
    • and operation of a current good manufacturing practices cell-engineering laboratory
    • Burger, S.R. Design and operation of a current good manufacturing practices cell-engineering laboratory. Cytotherapy 2, 111-122 (2000).
    • (2000) Cytotherapy , vol.2 , pp. 111-122
    • Burger, S.R.D.1
  • 19
    • 0036384913 scopus 로고    scopus 로고
    • Role of the GMP facility for adoptive immunotherapy
    • McMannis, J.D. & Champlin, R.E. Role of the GMP facility for adoptive immunotherapy. Cytotherapy 4, 329-331 (2002).
    • (2002) Cytotherapy , vol.4 , pp. 329-331
    • McMannis, J.D.1    Champlin, R.E.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.