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Volumn 10, Issue 1, 2012, Pages

Validation of analytical methods in GMP: The disposable Fast Read 102® device, an alternative practical approach for cell counting

Author keywords

Cell count; Cell factory; Cell therapy; GMP; Validation methods

Indexed keywords

REAGENT; TRYPAN BLUE; TUERK SOLUTION; UNCLASSIFIED DRUG;

EID: 84861638403     PISSN: None     EISSN: 14795876     Source Type: Journal    
DOI: 10.1186/1479-5876-10-112     Document Type: Article
Times cited : (29)

References (25)
  • 1
    • 78149270789 scopus 로고    scopus 로고
    • European Medicines Agency, Doc. Ref. EMEA/CHMP/410869/2006, Committee for Human Medicinal Products (CHMP)
    • Committee for Human Medicinal Products (CHMP) Guidelines on Human Cell-Based Medicinal Products European Medicines Agency, Doc. Ref. EMEA/CHMP/410869/2006, Committee for Human Medicinal Products (CHMP).
    • Guidelines on Human Cell-Based Medicinal Products
  • 6
    • 84869230534 scopus 로고    scopus 로고
    • The Rules Governing Medical Products in European Union. Good manufacturing practices
    • European Commission
    • European Commission The Rules Governing Medical Products in European Union. Good manufacturing practices. 1997, 4. European Commission.
    • (1997) , vol.4
  • 10
    • 80255126570 scopus 로고    scopus 로고
    • European Directorate for the Quality of Medicines & HealthCare (EDQM), 7
    • European Pharmacopoeia 2011, European Directorate for the Quality of Medicines & HealthCare (EDQM), 7.
    • (2011) European Pharmacopoeia
  • 15
    • 33747713246 scopus 로고    scopus 로고
    • Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement.
    • 10.1080/14653240600855905, 16923606
    • Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Horwitz E, Prockop D. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy 2006, 8:315-317. 10.1080/14653240600855905, 16923606.
    • (2006) Cytotherapy , vol.8 , pp. 315-317
    • Dominici, M.1    Le Blanc, K.2    Mueller, I.3    Slaper-Cortenbach, I.4    Marini, F.5    Krause, D.6    Deans, R.7    Keating, A.8    Horwitz, E.9    Prockop, D.10
  • 17
    • 58549115920 scopus 로고    scopus 로고
    • Clinical Protocols for the Isolation and Expansion of Mesenchymal Stromal Cells
    • 3076361, 21512644
    • Bieback K, Schallmoser K, Klüter H, Strunk D. Clinical Protocols for the Isolation and Expansion of Mesenchymal Stromal Cells. Transfus Med Hemother. 2008, 35:286-294. 3076361, 21512644.
    • (2008) Transfus Med Hemother. , vol.35 , pp. 286-294
    • Bieback, K.1    Schallmoser, K.2    Klüter, H.3    Strunk, D.4
  • 18
    • 79959436316 scopus 로고    scopus 로고
    • Translating research into clinical scale manufacturing of mesenchymal stromal cells
    • 2010:193519
    • Bieback K, Kinzebach S, Karagianni M. Translating research into clinical scale manufacturing of mesenchymal stromal cells. Stem Cells Int 2011, 20. 2010:193519.
    • (2011) Stem Cells Int , vol.20
    • Bieback, K.1    Kinzebach, S.2    Karagianni, M.3
  • 19
    • 84857804023 scopus 로고    scopus 로고
    • Mesenchymal stromal cells from human perinatal tissues: From biology to cell therapy
    • 3097927, 21607124
    • Bieback K, Brinkmann I. Mesenchymal stromal cells from human perinatal tissues: From biology to cell therapy. World J Stem Cells 2010, 2:81-92. 3097927, 21607124.
    • (2010) World J Stem Cells , vol.2 , pp. 81-92
    • Bieback, K.1    Brinkmann, I.2
  • 20
    • 70350650136 scopus 로고    scopus 로고
    • A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice
    • 10.1186/1479-5876-7-78, 2753319, 19737416
    • Soncin S, Lo Cicero V, Astori G, Soldati G, Gola M, Sürder D, Moccetti T. A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice. J Transl Med 2009, 7:78. 10.1186/1479-5876-7-78, 2753319, 19737416.
    • (2009) J Transl Med , vol.7 , pp. 78
    • Soncin, S.1    Lo Cicero, V.2    Astori, G.3    Soldati, G.4    Gola, M.5    Sürder, D.6    Moccetti, T.7
  • 21
    • 84870694277 scopus 로고    scopus 로고
    • Note
    • European Parliament and Council Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use,
  • 22
    • 84870705823 scopus 로고    scopus 로고
    • Note
    • Legislative decree N. 211/2003. Adoption of EC Directive 2001/20/EC related to the application of the good clinical practice in the execution of the clinical experimentations of medicines for clinical use,
  • 23
    • 84870723351 scopus 로고    scopus 로고
    • Note
    • European Parliament and Council Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products,
  • 24
    • 84870662343 scopus 로고    scopus 로고
    • Note
    • Legislative Decree N. 200/2007, Application of European Commission Directive 2005/28/EC of 8 April 2005 laying down the principles and detailed guidelines for good clinical practice concerning investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
  • 25
    • 84870663030 scopus 로고    scopus 로고
    • Note
    • Italian Minister of Health Decree dated 21st December 2007 on the procedure to follow for the authorization to the competent authority, for the communication of substantial amendments and the declaration of conclusion of the clinical trial and for the application to seem to the ethical committee,


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.