Reference materials for cellular therapeutics

Cytotherapy

Volumn 16, Issue 9, 2014, Pages 1187-1196

  Bravery, Christopher A ^a   French, Anna ^b  

^a Consulting on Advanced Biologicals Ltd Advanced Biologicals Ltd ^*  (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Cellular therapeutics; Metrology; Reference materials; Standards

Indexed keywords

ALPHA INTERFERON; ERYTHROPOIETIN; GRANULOCYTE COLONY STIMULATING FACTOR; HEMOGLOBIN;

ANALYTIC METHOD; CD4+ T LYMPHOCYTE; CELL THERAPY; ELECTRIC CURRENT; ENZYME LINKED IMMUNOSORBENT ASSAY; FLOW CYTOMETRY; GLYCOSYLATION; GOOD MANUFACTURING PRACTICE; HUMAN; MOLECULAR BIOLOGY; PRIORITY JOURNAL; QUALITY CONTROL; REFERENCE DATABASE; REVIEW; STANDARD; THERMODYNAMICS; TISSUE ENGINEERING; ANIMAL; BIOLOGICAL THERAPY; BOOK; CONSENSUS; CULTURE TECHNIQUE; GOVERNMENT REGULATION; PHYSIOLOGY; PROCEDURES; REPRODUCIBILITY; STANDARDS; STEM CELL;

ANIMALS; CELL CULTURE TECHNIQUES; CELL- AND TISSUE-BASED THERAPY; CONSENSUS; GOVERNMENT REGULATION; HUMANS; REFERENCE BOOKS, MEDICAL; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; STEM CELLS;

EID: 84905564687     PISSN: 14653249     EISSN: 14772566     Source Type: Journal    
DOI: 10.1016/j.jcyt.2014.05.024     Document Type: Review

References (27)

1. Allen R.H., Sriram R.D. The role of standards in innovation. Technol Forecast Social Change 2000, 64:171-181.
2. Griffiths B. Manufacturing paradigms: the role of standards in the past, the present and the future paradigm of sustainable manufacturing. Proceedings of the Institution of Mechanical Engineers, Part B: Journal of Engineering Manufacture October 2012 vol. 226 no. 10 1628-1634.
3. BSI Cell therapy and regenerative medicine glossary. Regen Med 2012, 7:S1-124.
4. Dominici M., Le Blanc K., Mueller I., Slaper-Cortenbach I., Marini F., Krause D., et al. Minimal criteria for defining multipotent mesenchymal stromal cells: the International Society for Cellular Therapy position statement. Cytotherapy 2006, 8:315-317.
5. Mendicino M., Bailey A.M., Wonnacott K., Puri R.K., Bauer S.R. MSC-based product characterization for clinical trials: an FDA perspective. Cell Stem Cell 2014, 14:141-145.
6. Judson L.V.H. Weights and measures standards of the United States: a brief history 1976, Department of Commerce, National Bureau of Standards: for sale by the Supt of Docs, US Government Printing Office, Washington, DC, iii:36.
7. Eurachem Guide: Terminology in Analytical Measurement: Introduction to VIM 3 2011, Available at:. http://www.eurachem.org, V.J. Barwick, E. Pritchard (Eds.).
8. Eurachem/CITAC Guide: Quantifying Uncertainty in Analytical Measurement 2012, Available at:. http://www.eurachem.org, 3rd edition. S.L.R. Ellison, A. William (Eds.).
9. Tai S.S., Welch M.J. Development and evaluation of a candidate reference method for the determination of total cortisol in human serum using isotope dilution liquid chromatography/mass spectrometry and liquid chromatography/tandem mass spectrometry. Anal Chem 2004, 76:1008-1014.
10. Zwart A., van Assendelft O.W., Bull B.S., England J.M., Lewis S.M., Zijlstra W.G. Recommendations for reference method for haemoglobinometry in human blood (ICSH standard 1995) and specifications for international haemiglobinocyanide standard (4th edition). J Clin Pathol 1996, 49:271-274.
11. Kammel M., Kummrow A., Neukammer J. Reference measurement procedures for the accurate determination of cell concentrations: present status and future developments/Referenzmessverfahren für die genaue Bestimmung von Zellkonzentrationen: Status und zukünftige Entwicklungen. Laboratoriums Medizin 2012, 25.
12. Roussel M., Davis B.H., Fest T., Wood B.L. (ICSH) ICfSiH. Toward a reference method for leukocyte differential counts in blood: comparison of three flow cytometric candidate methods. Cytometry A 2012, 81:973-982.
13. Hoffman R.A., Wang L., Bigos M., Nolan J.P. NIST/ISAC standardization study: variability in assignment of intensity values to fluorescence standard beads and in cross calibration of standard beads to hard dyed beads. Cytometry A 2012, 81:785-796.
14. Hultin L.E., Matud J.L., Giorgi J.V. Quantitation of CD38 activation antigen expression on CD8+ T cells in HIV-1 infection using CD4 expression on CD4+ T lymphocytes as a biological calibrator. Cytometry 1998, 33:123-132.
15. Wang L., Abbasi F., Ornatsky O., Cole K.D., Misakian M., Gaigalas A.K., et al. Human CD4+ lymphocytes for antigen quantification: characterization using conventional flow cytometry and mass cytometry. Cytometry A 2012, 81:567-575.
16. Davis B.H., Wood B., Oldaker T., Barnett D. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS, part I: rationale and aims. Cytometry B Clin Cytom 2013, 84:282-285.
17. Davis B.H., Dasgupta A., Kussick S., Han J.Y., Estrellado A. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS, part II: preanalytical issues. Cytometry B Clin Cytom 2013, 84:286-290. Group IIW.
18. Tanqri S., Vall H., Kaplan D., Hoffman B., Purvis N., Porwit A., et al. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS, part III: analytical issues. Cytometry B Clin Cytom 2013, 84:291-308.
19. Barnett D., Louzao R., Gambell P., De J., Oldaker T., Hanson C.A., et al. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS, part IV: postanalytic considerations. Cytometry B Clin Cytom 2013, 84:309-314.
20. Wood B., Jevremovic D., Béné M.C., Yan M., Jacobs P., Litwin V., et al. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS, part V: assay performance criteria. Cytometry B Clin Cytom 2013, 84:315-323.
21. Herzenberg L.A., Tung J., Moore W.A., Parks D.R. Interpreting flow cytometry data: a guide for the perplexed. Nat Immunol 2006, 7:681-685.
22. Baker S.C., Bauer S.R., Beyer R.P., Brenton J.D., Bromley B., Burrill J., et al. The External RNA Controls Consortium: a progress report. Nat Methods 2005, 2:731-734.
23. Jiang L., Schlesinger F., Davis C.A., Zhang Y., Li R., Salit M., et al. Synthetic spike-in standards for RNA-seq experiments. Genome Res 2011, 21:1543-1551.
24. Bravery C.A., Carmen J., Fong T., Oprea W., Hoogendoorn K.H., Woda J., et al. Potency assay development for cellular therapy products: an ISCT review of the requirements and experiences in the industry. Cytotherapy 2013, 15:9-19.
25. Viswanathan S., Keating A., Deans R., Hematti P., Prockop D., Stroncek D.F., et al. Soliciting strategies for developing cell-based reference materials to advance MSC research and clinical translation. Stem Cells and Development June 1, 2014, 23(11):1157-1167.
26. Krampera M., Galipeau J., Shi Y., Tarte K., Sensebe L. Immunological characterization of multipotent mesenchymal stromal cells: the International Society for Cellular Therapy (ISCT) working proposal. Cytotherapy 2013, 15:1054-1061. (ISCT) MCotISfCT.
27. Szymczak M.M., Friedman R.L., Uppoor R., Yacobi A. FDA/Industry Perspectives: detection, Measurement, and Control in Manufacturing. Pharmaceutical Technology [Internet] 2011, 35:70-74. Available at:. http://www.pharmtech.com/pharmtech/Regulatory+Corner/FDAIndustry-Perspectives-Detection-Measurement-and/ArticleStandard/Article/detail/742137.