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Volumn , Issue 1, 2009, Pages 32-37

PAT and QbD aspects on stem cell manufacture

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; CELL CULTURE; CELL DIFFERENTIATION; CELL EXPANSION; CELL ISOLATION; CELL TYPE; DRUG DESIGN; DRUG INDUSTRY; DRUG RESEARCH; GOOD MANUFACTURING PRACTICE; INNER CELL MASS; PROCESS ANALYTICAL TECHNOLOGY; PROCESS DEVELOPMENT; PROCESS TECHNOLOGY; QUALITY BY DESIGN; QUALITY CONTROL; REVIEW; STEM CELL;

EID: 77953410045     PISSN: 13608606     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review
Times cited : (7)

References (23)
  • 2
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    • Process analytical technology in biotechnology
    • Mandenius CF (2006) Process analytical technology in biotechnology, Eur Pharm Rev 11, 69-76.
    • (2006) Eur Pharm Rev , vol.11 , pp. 69-76
    • Mandenius, C.F.1
  • 4
    • 77953381607 scopus 로고    scopus 로고
    • International Conference on harmonization of technical requirements for registration of pharmaceuticals for human use ICH, Document ICH Q9 Quality Risk Management, 2006
    • International Conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ICH). Document ICH Q9 Quality Risk Management, 2006
  • 5
    • 77953446795 scopus 로고    scopus 로고
    • International Conference on harmonization of technical requirements for registration of pharmaceuticals for human use ICH, Document ICH Q10 Note for guidance on Pharmaceutical Quality Systems, 2008
    • International Conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ICH). Document ICH Q10 Note for guidance on Pharmaceutical Quality Systems, 2008
  • 6
    • 55549112824 scopus 로고    scopus 로고
    • The challenge of regulatory stem cell-based products
    • von Tigerstrom BJ (2008) The challenge of regulatory stem cell-based products, Trends Biotechnol 26, 653-658.
    • (2008) Trends Biotechnol , vol.26 , pp. 653-658
    • von Tigerstrom, B.J.1
  • 7
    • 77953413668 scopus 로고    scopus 로고
    • European Commission, Directive of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, E.C. Directive 2004/23 (2004)
    • European Commission, Directive of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, E.C. Directive 2004/23 (2004)
  • 10
    • 34548386096 scopus 로고    scopus 로고
    • The application of human embryonic stem cell technologies to drug discovery
    • Sartipy P, Björquist P, Strehl R, Hyllner J (2007) The application of human embryonic stem cell technologies to drug discovery, Drug Discovery Today 12, 688-699.
    • (2007) Drug Discovery Today , vol.12 , pp. 688-699
    • Sartipy, P.1    Björquist, P.2    Strehl, R.3    Hyllner, J.4
  • 13
    • 34447295350 scopus 로고    scopus 로고
    • Characterization of human embryonic stem cell lines by the international stem cell initiative
    • Adewumi O, et al (2007) Characterization of human embryonic stem cell lines by the international stem cell initiative, Nature Biotechnol 25:803-816.
    • (2007) Nature Biotechnol , vol.25 , pp. 803-816
    • Adewumi, O.1
  • 14
    • 34247524516 scopus 로고    scopus 로고
    • Monitoring and analysis of dynamic growth of human embryonic stem cells, comparison of automated instrumentation and conventional culturing methods
    • Narkilahti S, Rajala K, Pihlajamäki H, Suuronen R, Hovatta O, Skottman H (2007) Monitoring and analysis of dynamic growth of human embryonic stem cells, comparison of automated instrumentation and conventional culturing methods, Biomed Eng Online 6:11, 1-8
    • (2007) Biomed Eng Online , vol.6 , Issue.11 , pp. 1-8
    • Narkilahti, S.1    Rajala, K.2    Pihlajamäki, H.3    Suuronen, R.4    Hovatta, O.5    Skottman, H.6
  • 15
    • 8744311411 scopus 로고    scopus 로고
    • Quantitative screening of embryonic stem cell differentiation: Endoderm formation as a model
    • Chang KH, Zandstra PW. Quantitative screening of embryonic stem cell differentiation: endoderm formation as a model. Biotechnol Bioeng. 2004;88:287-298.
    • (2004) Biotechnol Bioeng , vol.88 , pp. 287-298
    • Chang, K.H.1    Zandstra, P.W.2
  • 22
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    • Cambridge UK
    • The Automation Partnership, Cambridge (UK), http://www. automationpartnership.com/
    • The Automation Partnership
  • 23
    • 77953470071 scopus 로고    scopus 로고
    • Smart cell culture,
    • European Patent Application EP 1598415
    • Drake RAL, Oakeshott RBS (2005) Smart cell culture, European Patent Application EP 1598415
    • (2005)
    • Drake, R.A.L.1    Oakeshott, R.B.S.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.