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2017 | OriginalPaper | Buchkapitel

Validation—The Key to Translatable Cytometry in the 21st Century

verfasst von : Virginia Litwin, Cherie Green, Alessandra Vitaliti

Erschienen in: Single Cell Analysis

Verlag: Springer Singapore

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Abstract

With the primary goal of translating scientific advances and innovative technologies to applications that directly benefit patient care and treatment, Translational Science has justifiably generated considerable enthusiasm. Unfortunately, this enthusiasm has been somewhat tampered by the reality that the outcomes have not fully met the expectations of accelerating the transition of new discoveries from the bench to the bedside. This failure to deliver can be attributed, in part, to the lack of reproducible standards and procedures. Thus it stands to reason that suggestions for increasing the success rate of the Translation Science initiative include the implementation of more robust methods, standardization and validation. This chapter will explore opportunities in the translational science space and key concepts of analytical method validation as applied to cytometry.

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Literatur
2.
Zurück zum Zitat Reis SE, Berglund L, Bernard GR, Califf RM, Fitzgerald GA, Johnson PC, National C, and Translational Science Awards C (2010) Reengineering the national clinical and translational research enterprise: the strategic plan of the National Clinical and Translational Science Awards Consortium. Acad Med 85:463–469. doi:10.1097/ACM.0b013e3181ccc877 CrossRef Reis SE, Berglund L, Bernard GR, Califf RM, Fitzgerald GA, Johnson PC, National C, and Translational Science Awards C (2010) Reengineering the national clinical and translational research enterprise: the strategic plan of the National Clinical and Translational Science Awards Consortium. Acad Med 85:463–469. doi:10.​1097/​ACM.​0b013e3181ccc877​ CrossRef
3.
6.
Zurück zum Zitat Sklar AL, Edwards SB (2011) HTS flow cytometry, small molecule discovery, and the NIH molecular libraries initiative, in flow cytometry in drug discover and development. In: Litwin V, Marder P (eds). Wiley, New Jersey Sklar AL, Edwards SB (2011) HTS flow cytometry, small molecule discovery, and the NIH molecular libraries initiative, in flow cytometry in drug discover and development. In: Litwin V, Marder P (eds). Wiley, New Jersey
7.
Zurück zum Zitat Yuan J, Hegde PS, Clynes R, Foukas PG, Harari A, Kleen TO, Kvistborg P, Maccalli C, Maecker HT, Page DB, Robins H, Song W, Stack EC, Wang E, Whiteside TL, Zhao Y, Zwierzina H, Butterfield LH, Fox BA (2016) Novel technologies and emerging biomarkers for personalized cancer immunotherapy. J Immunother Cancer 4:3. doi:10.1186/s40425-016-0107-3 CrossRef Yuan J, Hegde PS, Clynes R, Foukas PG, Harari A, Kleen TO, Kvistborg P, Maccalli C, Maecker HT, Page DB, Robins H, Song W, Stack EC, Wang E, Whiteside TL, Zhao Y, Zwierzina H, Butterfield LH, Fox BA (2016) Novel technologies and emerging biomarkers for personalized cancer immunotherapy. J Immunother Cancer 4:3. doi:10.​1186/​s40425-016-0107-3 CrossRef
12.
Zurück zum Zitat Gergely P, Nuesslein-Hildesheim B, Guerini D, Brinkmann V, Traebert M, Bruns C, Pan S, Gray NS, Hinterding K, Cooke NG, Groenewegen A, Vitaliti A, Sing T, Luttringer O, Yang J, Gardin A, Wang N, Crumb WJ Jr, Saltzman M, Rosenberg M, Wallstrom E (2012) The selective sphingosine 1-phosphate receptor modulator BAF312 redirects lymphocyte distribution and has species-specific effects on heart rate. Br J Pharmacol 167:1035–1047. doi:10.1111/j.1476-5381.2012.02061.x CrossRef Gergely P, Nuesslein-Hildesheim B, Guerini D, Brinkmann V, Traebert M, Bruns C, Pan S, Gray NS, Hinterding K, Cooke NG, Groenewegen A, Vitaliti A, Sing T, Luttringer O, Yang J, Gardin A, Wang N, Crumb WJ Jr, Saltzman M, Rosenberg M, Wallstrom E (2012) The selective sphingosine 1-phosphate receptor modulator BAF312 redirects lymphocyte distribution and has species-specific effects on heart rate. Br J Pharmacol 167:1035–1047. doi:10.​1111/​j.​1476-5381.​2012.​02061.​x CrossRef
13.
Zurück zum Zitat Kovarik JM, Stitah S, Slade A, Vitaliti A, Straube F, Grenet O, Winter S, Sfikas N, Seiberling M (2010) Sotrastaurin and tacrolimus coadministration: effects on pharmacokinetics and biomarker responses. J Clin Pharmacol 50:1260–1266. doi:10.1177/0091270009360534 CrossRef Kovarik JM, Stitah S, Slade A, Vitaliti A, Straube F, Grenet O, Winter S, Sfikas N, Seiberling M (2010) Sotrastaurin and tacrolimus coadministration: effects on pharmacokinetics and biomarker responses. J Clin Pharmacol 50:1260–1266. doi:10.​1177/​0091270009360534​ CrossRef
14.
Zurück zum Zitat Perl AE, Kasner MT, Shank D, Luger SM, Carroll M (2012) Single-cell pharmacodynamic monitoring of S6 ribosomal protein phosphorylation in AML blasts during a clinical trial combining the mTOR inhibitor sirolimus and intensive chemotherapy. Clin Cancer Res 18:1716–1725. doi:10.1158/1078-0432.CCR-11-2346 CrossRef Perl AE, Kasner MT, Shank D, Luger SM, Carroll M (2012) Single-cell pharmacodynamic monitoring of S6 ribosomal protein phosphorylation in AML blasts during a clinical trial combining the mTOR inhibitor sirolimus and intensive chemotherapy. Clin Cancer Res 18:1716–1725. doi:10.​1158/​1078-0432.​CCR-11-2346 CrossRef
15.
Zurück zum Zitat Pers JO, Devauchelle V, Daridon C, Bendaoud B, Le Berre R, Bordron A, Hutin P, Renaudineau Y, Dueymes M, Loisel S, Berthou C, Saraux A, Youinou P (2007) BAFF-modulated repopulation of B lymphocytes in the blood and salivary glands of rituximab-treated patients with Sjogren’s syndrome. Arthritis Rheum 56:1464–1477. doi:10.1002/art.22603 CrossRef Pers JO, Devauchelle V, Daridon C, Bendaoud B, Le Berre R, Bordron A, Hutin P, Renaudineau Y, Dueymes M, Loisel S, Berthou C, Saraux A, Youinou P (2007) BAFF-modulated repopulation of B lymphocytes in the blood and salivary glands of rituximab-treated patients with Sjogren’s syndrome. Arthritis Rheum 56:1464–1477. doi:10.​1002/​art.​22603 CrossRef
16.
Zurück zum Zitat Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, Keller S, Weinryb I, Green M, Duan L, Rogers JA, Millham R, O’Brien PJ, Sailstad J, Khan M, Ray C, Wagner JA (2006) Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res 23:312–328. doi:10.1007/s11095-005-9045-3 CrossRef Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, Keller S, Weinryb I, Green M, Duan L, Rogers JA, Millham R, O’Brien PJ, Sailstad J, Khan M, Ray C, Wagner JA (2006) Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res 23:312–328. doi:10.​1007/​s11095-005-9045-3 CrossRef
18.
19.
Zurück zum Zitat Sommer U, Morales J, Groenewegen A, Muller A, Naab J, Woerly G, Kamphausen E, Marsot H, Bennett P, Kakkanaiah V, Vitaliti A (2015) Implementation of highly sophisticated flow cytometry assays in multicenter clinical studies: considerations and guidance. Bioanalysis 7:1299–1311. doi:10.4155/bio.15.61 CrossRef Sommer U, Morales J, Groenewegen A, Muller A, Naab J, Woerly G, Kamphausen E, Marsot H, Bennett P, Kakkanaiah V, Vitaliti A (2015) Implementation of highly sophisticated flow cytometry assays in multicenter clinical studies: considerations and guidance. Bioanalysis 7:1299–1311. doi:10.​4155/​bio.​15.​61 CrossRef
20.
Zurück zum Zitat Tanqri S, Vall H, Kaplan D, Hoffman B, Purvis N, Porwit A, Hunsberger B, Shankey TV, Group IIW (2013) Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS—part III—analytical issues. Cytometry B Clin Cytom 84:291–308. doi:10.1002/cyto.b.21106 Tanqri S, Vall H, Kaplan D, Hoffman B, Purvis N, Porwit A, Hunsberger B, Shankey TV, Group IIW (2013) Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS—part III—analytical issues. Cytometry B Clin Cytom 84:291–308. doi:10.​1002/​cyto.​b.​21106
21.
Zurück zum Zitat Wood B, Jevremovic D, Bene MC, Yan M, Jacobs P, Litwin V, Group IIW (2013) Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS—part V—assay performance criteria. Cytometry B Clin Cytometry 84:315–23. doi:10.1002/cyto.b.21108 Wood B, Jevremovic D, Bene MC, Yan M, Jacobs P, Litwin V, Group IIW (2013) Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS—part V—assay performance criteria. Cytometry B Clin Cytometry 84:315–23. doi:10.​1002/​cyto.​b.​21108
22.
Zurück zum Zitat Green CL, Brown L, Stewart JJ, Xu Y, Litwin V, Mc Closkey TW (2011) Recommendations for the validation of flow cytometric testing during drug development: I instrumentation. J Immunol Methods 363:104–119. doi:10.1016/j.jim.2010.07.004 CrossRef Green CL, Brown L, Stewart JJ, Xu Y, Litwin V, Mc Closkey TW (2011) Recommendations for the validation of flow cytometric testing during drug development: I instrumentation. J Immunol Methods 363:104–119. doi:10.​1016/​j.​jim.​2010.​07.​004 CrossRef
23.
Zurück zum Zitat Perfetto SP, Ambrozak D, Nguyen R, Chattopadhyay PK, Roederer M (2012) Quality assurance for polychromatic flow cytometry using a suite of calibration beads. Nat Protoc 7:2067–2079. doi:10.1038/nprot.2012.126 CrossRef Perfetto SP, Ambrozak D, Nguyen R, Chattopadhyay PK, Roederer M (2012) Quality assurance for polychromatic flow cytometry using a suite of calibration beads. Nat Protoc 7:2067–2079. doi:10.​1038/​nprot.​2012.​126 CrossRef
26.
Zurück zum Zitat McLaughlin BE, Baumgarth N, Bigos M, Roederer M, De Rosa SC, Altman JD, Nixon DF, Ottinger J, Li J, Beckett L, Shacklett BL, Evans TG, Asmuth DM (2008) Nine-color flow cytometry for accurate measurement of T cell subsets and cytokine responses. Part II: Panel performance across different instrument platforms. Cytometry A 73:411–420. doi:10.1002/cyto.a.20556 CrossRef McLaughlin BE, Baumgarth N, Bigos M, Roederer M, De Rosa SC, Altman JD, Nixon DF, Ottinger J, Li J, Beckett L, Shacklett BL, Evans TG, Asmuth DM (2008) Nine-color flow cytometry for accurate measurement of T cell subsets and cytokine responses. Part II: Panel performance across different instrument platforms. Cytometry A 73:411–420. doi:10.​1002/​cyto.​a.​20556 CrossRef
27.
Zurück zum Zitat McLaughlin BE, Baumgarth N, Bigos M, Roederer M, De Rosa SC, Altman JD, Nixon DF, Ottinger J, Oxford C, Evans TG, Asmuth DM (2008) Nine-color flow cytometry for accurate measurement of T cell subsets and cytokine responses. Part I: Panel design by an empiric approach. Cytometry A 73:400–410. doi:10.1002/cyto.a.20555 CrossRef McLaughlin BE, Baumgarth N, Bigos M, Roederer M, De Rosa SC, Altman JD, Nixon DF, Ottinger J, Oxford C, Evans TG, Asmuth DM (2008) Nine-color flow cytometry for accurate measurement of T cell subsets and cytokine responses. Part I: Panel design by an empiric approach. Cytometry A 73:400–410. doi:10.​1002/​cyto.​a.​20555 CrossRef
28.
Zurück zum Zitat Hoffman RA, Wang L, Bigos M, Nolan JP (2012) 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 81:785–796. doi:10.1002/cyto.a.22086 CrossRef Hoffman RA, Wang L, Bigos M, Nolan JP (2012) 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 81:785–796. doi:10.​1002/​cyto.​a.​22086 CrossRef
29.
Zurück zum Zitat Davis BH, McLaren CE, Carcio AJ, Wong L, Hedley BD, Keeney M, Curtis A, Culp NB (2013) Determination of optimal replicate number for validation of imprecision using fluorescence cell-based assays: proposed practical method. Cytometry B Clin Cytometry 84:329–337. doi:10.1002/cyto.b.21116 CrossRef Davis BH, McLaren CE, Carcio AJ, Wong L, Hedley BD, Keeney M, Curtis A, Culp NB (2013) Determination of optimal replicate number for validation of imprecision using fluorescence cell-based assays: proposed practical method. Cytometry B Clin Cytometry 84:329–337. doi:10.​1002/​cyto.​b.​21116 CrossRef
31.
Zurück zum Zitat Brown L, Green CL, Jones N, Stewart JJ, Fraser S, Howell K, Xu Y, Hill CG, Wiwi CA, White WI, O’Brien PJ, Litwin V (2015) Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development. J Immunol Methods 418:1–8. doi:10.1016/j.jim.2015.01.008 CrossRef Brown L, Green CL, Jones N, Stewart JJ, Fraser S, Howell K, Xu Y, Hill CG, Wiwi CA, White WI, O’Brien PJ, Litwin V (2015) Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development. J Immunol Methods 418:1–8. doi:10.​1016/​j.​jim.​2015.​01.​008 CrossRef
32.
Zurück zum Zitat Rawstron AC, Orfao A, Beksac M, Bezdickova L, Brooimans RA, Bumbea H, Dalva K, Fuhler G, Gratama J, Hose D, Kovarova L, Lioznov M, Mateo G, Morilla R, Mylin AK, Omede P, Pellat-Deceunynck C, Perez Andres M, Petrucci M, Ruggeri M, Rymkiewicz G, Schmitz A, Schreder M, Seynaeve C, Spacek M, de Tute RM, Van Valckenborgh E, Weston-Bell N, Owen RG, San Miguel JF, Sonneveld P, Johnsen HE, European Myeloma N (2008) Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders. Haematologica 93:431–438. doi:10.3324/haematol.11080 CrossRef Rawstron AC, Orfao A, Beksac M, Bezdickova L, Brooimans RA, Bumbea H, Dalva K, Fuhler G, Gratama J, Hose D, Kovarova L, Lioznov M, Mateo G, Morilla R, Mylin AK, Omede P, Pellat-Deceunynck C, Perez Andres M, Petrucci M, Ruggeri M, Rymkiewicz G, Schmitz A, Schreder M, Seynaeve C, Spacek M, de Tute RM, Van Valckenborgh E, Weston-Bell N, Owen RG, San Miguel JF, Sonneveld P, Johnsen HE, European Myeloma N (2008) Report of the European Myeloma Network on multiparametric flow cytometry in multiple myeloma and related disorders. Haematologica 93:431–438. doi:10.​3324/​haematol.​11080 CrossRef
35.
Zurück zum Zitat Hoffman RA (2001) Standardization and quantitation in flow cytometry. Methods Cell Biol 63:299–340CrossRef Hoffman RA (2001) Standardization and quantitation in flow cytometry. Methods Cell Biol 63:299–340CrossRef
37.
Zurück zum Zitat Kalina T, Flores-Montero J, van der Velden VH, Martin-Ayuso M, Bottcher S, Ritgen M, Almeida J, Lhermitte L, Asnafi V, Mendonca A, de Tute R, Cullen M, Sedek L, Vidriales MB, Perez JJ, te Marvelde JG, Mejstrikova E, Hrusak O, Szczepanski T, van Dongen JJ, Orfao A, EuroFlow C (2012) EuroFlow standardization of flow cytometer instrument settings and immunophenotyping protocols. Leukemia 26:1986–2010. doi:10.1038/leu.2012.122 CrossRef Kalina T, Flores-Montero J, van der Velden VH, Martin-Ayuso M, Bottcher S, Ritgen M, Almeida J, Lhermitte L, Asnafi V, Mendonca A, de Tute R, Cullen M, Sedek L, Vidriales MB, Perez JJ, te Marvelde JG, Mejstrikova E, Hrusak O, Szczepanski T, van Dongen JJ, Orfao A, EuroFlow C (2012) EuroFlow standardization of flow cytometer instrument settings and immunophenotyping protocols. Leukemia 26:1986–2010. doi:10.​1038/​leu.​2012.​122 CrossRef
38.
Zurück zum Zitat Maecker HT, McCoy JP, Nussenblatt R (2012) Standardizing immunophenotyping for the human immunology project. Nat Rev Immunol 12:191–200. doi:10.1038/nri3158 Maecker HT, McCoy JP, Nussenblatt R (2012) Standardizing immunophenotyping for the human immunology project. Nat Rev Immunol 12:191–200. doi:10.​1038/​nri3158
39.
Zurück zum Zitat van Dongen JJ, Lhermitte L, Bottcher S, Almeida J, van der Velden VH, Flores-Montero J, Rawstron A, Asnafi V, Lecrevisse Q, Lucio P, Mejstrikova E, Szczepanski T, Kalina T, de Tute R, Bruggemann M, Sedek L, Cullen M, Langerak AW, Mendonca A, Macintyre E, Martin-Ayuso M, Hrusak O, Vidriales MB, Orfao A, EuroFlow C (2012) EuroFlow antibody panels for standardized n-dimensional flow cytometric immunophenotyping of normal, reactive and malignant leukocytes. Leukemia 26:1908–1975. doi:10.1038/leu.2012.120 CrossRef van Dongen JJ, Lhermitte L, Bottcher S, Almeida J, van der Velden VH, Flores-Montero J, Rawstron A, Asnafi V, Lecrevisse Q, Lucio P, Mejstrikova E, Szczepanski T, Kalina T, de Tute R, Bruggemann M, Sedek L, Cullen M, Langerak AW, Mendonca A, Macintyre E, Martin-Ayuso M, Hrusak O, Vidriales MB, Orfao A, EuroFlow C (2012) EuroFlow antibody panels for standardized n-dimensional flow cytometric immunophenotyping of normal, reactive and malignant leukocytes. Leukemia 26:1908–1975. doi:10.​1038/​leu.​2012.​120 CrossRef
40.
Zurück zum Zitat Rawstron AC, Bottcher S, Letestu R, Villamor N, Fazi C, Kartsios H, de Tute RM, Shingles J, Ritgen M, Moreno C, Lin K, Pettitt AR, Kneba M, Montserrat E, Cymbalista F, Hallek M, Hillmen P, Ghia P, European Research Initiative in CLL (2013) Improving efficiency and sensitivity: European Research Initiative in CLL (ERIC) update on the international harmonised approach for flow cytometric residual disease monitoring in CLL. Leukemia 27:142–9. doi:10.1038/leu.2012.216 Rawstron AC, Bottcher S, Letestu R, Villamor N, Fazi C, Kartsios H, de Tute RM, Shingles J, Ritgen M, Moreno C, Lin K, Pettitt AR, Kneba M, Montserrat E, Cymbalista F, Hallek M, Hillmen P, Ghia P, European Research Initiative in CLL (2013) Improving efficiency and sensitivity: European Research Initiative in CLL (ERIC) update on the international harmonised approach for flow cytometric residual disease monitoring in CLL. Leukemia 27:142–9. doi:10.​1038/​leu.​2012.​216
Metadaten
Titel
Validation—The Key to Translatable Cytometry in the 21st Century
verfasst von
Virginia Litwin
Cherie Green
Alessandra Vitaliti
Copyright-Jahr
2017
Verlag
Springer Singapore
DOI
https://doi.org/10.1007/978-981-10-4499-1_6

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