Development and validation of flow cytometry methods for pharmacodynamic clinical biomarkers

Bioanalysis

Volumn 2, Issue 9, 2010, Pages 1617-1626

  Wu, Dianna Y ^a   Patti Diaz, Lisa ^a   Hill, Carla G ^b  

^a BRISTOL MYERS SQUIBB   (United States)

^b ICON Central Laboratories   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; FLUOROCHROME; MONOCLONAL ANTIBODY; REAGENT;

ACCURACY; ANTIBODY SPECIFICITY; ANTIGEN BINDING; APOPTOSIS; BIOCHEMICAL EQUIPMENT; BLOOD SAMPLING; CELL PROLIFERATION; CLINICAL CHEMISTRY; CLINICAL PHARMACOLOGY; CLINICAL PRACTICE; CLINICAL PROTOCOL; FLOW CYTOMETRY; HUMAN; IMMUNOPHENOTYPING; INFORMATION PROCESSING; MEDICAL EDUCATION; MEDICAL RESEARCH; MOLECULAR STABILITY; PERIPHERAL BLOOD MONONUCLEAR CELL; PHARMACODYNAMICS; PROCESS DEVELOPMENT; PROCESS MONITORING; PROCESS OPTIMIZATION; PROTEIN DETERMINATION; PROTEIN EXPRESSION; PROTEIN PHOSPHORYLATION; PROTEIN TARGETING; QUALITY CONTROL; REVIEW; STANDARDIZATION; STORAGE; VALIDATION PROCESS; METHODOLOGY; STANDARD; VALIDATION STUDY;

BIOLOGICAL MARKERS; BIOMEDICAL RESEARCH; FLOW CYTOMETRY; HUMANS; VALIDATION STUDIES AS TOPIC;

EID: 79952513946     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.33     Document Type: Review

References (56)

1. Biomarkers Defnitions Working Group (NIH). Biomarkers and surrogate endpoints: preferred defnitions and conceptual framework. Clin. Pharmacol. Ther. 69, 89-95 (2001).
2. Lee WL, Weiner ES, Sailstad JM et al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report. Phar. Res. 22(4), 499-511 (2005). (Pubitemid 40603246)
3. Robinson P, Darzynkiewicz Z, Dean PN et al. Current Protocols in Cytometry. John Wiley and Sons, NY, USA (2009).
4. + hematopoietic stem and progenitor cells. Cytometry 34, 128-142 (1998).
5. Calvelli T, Denny TN, Paxton H et al. Guideline for fow cytometric immunophenotyping: a report from the National Institute of Allergy and Infectious Diseases, Division of AIDS. Cytometry 14, 702-714 (1993).
6. Cunliffe J, Derbyshire N, Keeler S, Coldwell R. An Approach to the validation of fow cytometry methods. Pharm. Res. 22(12), 2551-2557 (2009).
7. Lee JW, Devanarayan V, Barrett YC et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23(2), 312-328 (2006) (Pubitemid 43237862)
8. Kruisbeek A, Shevach E, Thorton A. Proliferative assays for T cell function. In: Current Protocols in Immunology. Coico R (Ed.) John Wiley and Sons, NY, USA, 3, 12 (2004).
9. Arkin CF, Davis BH, Bessman JD et al. Approved Guideline-Second Edition. Methods for reticulocyte counting (automated blood cell counters, fow cytometry and supravital dyes). Clinical and Laboratory Standards Institute (Volume 24), H44-A2 (2004).
10. Stetler-Stevenson M, Ahmad E, Barnett D et al. Approved Guideline-Second Edition. Clinical fow cytometric analysis of neoplastic hematolymphoid cells. Clinical and Laboratory Standards Institute (Volume 27), H43-A2 (2007).
11. Krutzik PO, Irish JM, Nolan GP, Perez OD. Analysis of protein phosphorylation and cellular signaling events by fow cytometry; techniques and clinical applications. Clin. Immunol. 110, 206-221 (2004). (Pubitemid 38402001)
12. Chau CH, Rixe O, McLeod H, Figg W. Validation of analytic methods for biomarkers used in drug development. Clin. Cancer Res. 14(19), 5967-5976 (2008).
13. Reimann KA, Chernoff M, Wilkening CL, Nickerson CE, Landay AL. The ACTG Immunology Advanced Technology Laboratories. Preservation of lymphocyte immunophenotype and proliferative responses in cryopreserved peripheral blood mononuclear cells from human immunodefciency virus type 1-infected donors: implications for multicenter clinical trials. Clin. Diag. Lab. Immunol. 7(3), 352-359 (2000). (Pubitemid 30263024)
14. Maecker HT, Moon J, Bhatia S et al. Impact of cryopreservation on tetramer, cytokine fow cytometry, and ELISPOT BMC Immunol. 6, 17 (2005).
15. Patti-Diaz L, Wu YD. Development of a fow cytometric assay to evaluate naive and memory T cell populations in human peripheral blood mononuclear cells. Presented at: ISAC XXIII International Congress. Quebec City, QC, Canada, 20-26 May 2006.
16. Disis M, dela Rosa C, Goodell V et al. Maximizing the retention of antigen specifc lymphocyte function after cryopreservation. J. Immunol. Meth. 308, 13-18 (2006). (Pubitemid 43107950)
17. Ruitenberg JJ, Mulder CB, Maino VC, Landay AL, Ghanekar SA. Vacutainer® CPT® and fcoll density gradient separation perform equivalently in maintaining the quality and function of PBMC from HIV seropositive blood samples. BMC Immunol. 7, 11 (2006).
18. Bull M, Lee D, Stucky J, Chiu Y, Rubin A, Horton H, McElrath MJ. Defning blood processing parameters for optimal detection of cryopreserved antigen-specifc responses for HIV vaccine trials. J. Immun. Methods 322-(1-2), 57-69. (2007) (Pubitemid 46560582)
19. Cosentino LM, Corwin W, Baust JM et al. Preliminary report: evaluation of storage conditions and cryococktails during peripheral blood mononuclear cell cryopreservation. Cell Preserv. Technol. 5(4), 189-204 (2007).
20. Weinberg A, Zhang L, Brown D et al. Viability and fnctional activity of cryopreserved mononuclear cells. Clin. Diag Lab. Immunol. 7(4), 714-716 (2000). (Pubitemid 30463241)
21. Green L, Marder P, Ray C et al. Development and validation of a drug activity biomarker that shows target inhibition in cancer patients receiving enzastaurin, a novel protein kinase C-ß inhibitor. Clin. Cancer Res. 12(11), 3409-3415 (2006).
22. Chattopadhyay PK, Hogerkorp CM, Roederer M. A chromatic explosion: the development and future of multiparameter fow cytometry. Immunology 125(4), 441-449 (2008).
23. Horton H, Thomas EP, Stucky JA et al. Optimization and validation of an 8-color intracellular cytokine staining (ICS) assay to quantify antigen-specifc T cells induced by vaccination. J. Immunol. Meth. 323, 39-54 (2007). (Pubitemid 46722712)
24. Wu D. Standardization of a fow cytometry assay to measure protein expression on monocytes in human whole blood. Presented at: AAPS National Biotechnology Conference, San Diego, CA, USA, 24-27 June 2007.
25. Mahnke Y, Roederer M. Optimizing a multi-color immunophenotyping assay Clin. Lab. Med. 27(3), 469 (2007).
26. Wood BL. Ten-color immunophenotyping of hematopoietic cells. In: Current Protocols in Cytometry. Robinson JP (Ed.), John Wiley and Sons, NY, USA, 6.21.1-6.21.4 (2005).
27. Stelzer GT, Marti G, Hurley A, McCoy P, Lovett EJ, Schwartz A. U.S.-Canadian consensus recomemendations on the immunophenotypic analysis of hematologic neoplasia by fow cytometry: standardization and validation of laboratory procedures. Cytometry 30, 214-230 (1997).
28. Roederer M. Spectral compensation for fow cytometry: visualization artifacts, limitations, and caveats. Cytometry 45,194-205 (2001). (Pubitemid 33064141)
29. Purvis N, Stelzer G. Multi-platform, multi-site instrumentation and reagent standardization. Cytometry 33, 156-165 (1998). (Pubitemid 28447140)
30. Maecker HT, Trotter J. Flow cytometrty controls, instrument setup and determination of positivity. Cytometry 69, 1037-1042 (2006). (Pubitemid 44521985)
31. Stewart CC, Stewart SJ. Titering antibodies. In: Current Protocols in Cytometry. Robinson JP (Ed.), John Wiley and Sons, NY, USA, 4.1.1-4.1.13 (1997).
32. BD Biosciences Technical Bulletin: Introduction to compensation for multicolor assays on digital fow cytometers. BD Biosciences (2009).
33. Tung JW, Parks DR, Moore WA, Herzenberg LA, Herzenberg LA. New approaches to fuorescence compensation and visualization of FACS data. Clin. Immnol. 110, 277-283 (2004). (Pubitemid 38402007)
34. Latek R, Fleener C, Lamian V et al. Assessment of belatacept-mediated costimulation blockade through evaluation of CD80/86-receptor saturation. Transplantation 87(6), 926-933 (2009)
35. Schwartz A, Gaigalas AK, Wang L, Marti GE, Vogt RF, Fernandez-Repollet E. Formalization of the MESF unit of fuorescence intensity Cytometry B 57B, 1-6 (2004). (Pubitemid 38297617)
36. Hilt E, Fleener C, Robinson D et al. Fit-for-purpose method validation for a fow cytometry-based CD86 receptor competition assay to measure receptor saturation by belatacept (BMS-224818; LEA29Y). Presented at: AAPS National Biotechnology Conference, San Diego, CA, USA, 24-27 June 2007
37. Mittag A, Tarnok A. Basics of standardization and calibration in cytometry-a review. J. Biophotonics (8-9), 470-481 (2009).
38. Wyant T, Lackey A, Green M. Validation of a fow cytometry based chemokine internalization assay for use in evaluating the pharmacodynamic response to a receptor antagonist. J. Transl. Med. 6, 76 (2008).
39. Cummings J, Ward TH, Greystoke A, Ranson M, Dive C. Biomarker method validation in anticancer drug development. Br. J. Pharmacol. 153, 646-656 (2008). (Pubitemid 351271750)
40. Weinberg A, Song L, Wilkening C et al. Optimization and limitations of use of cryopreserved peripheral blood mononuclear cells for functional and phenotypic T-cell characterization. Clin. Vaccine Immunol. 16(8), 1176-1186 (2009).
41. Maecker HT, Hassler, J, Payne J et al. Precision and linearity targets for validation of an IFNγ elispot, cytokine fow cytometry and tetramer assay using CMV peptides. BMC Immunol. 9, 9 (2008).
42. Ezzelle J, Rodriguez-Chavez IR, Darden JM et al. Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. J. Pharm. Biomed. Anal. 46(1), 18-29 (2008). (Pubitemid 350216340)
43. Wood JCS, Hoffman RA. Evaluating fuorescence sensitivity on fow cytometers: an overview. Cytometry 33, 256-259 (1998). (Pubitemid 28447152)
44. Stall A, Qr and Br in BD FACSDiva v6 Software; parameters for characterizing detector performance. BD Biosciences Application Note (2008).
45. Wood JCS. Establishing and maintaining system linearity. In: Current Protocols in Cytometry, Robinson JP (Ed.), John Wiley and Sons, NY, USA, 1.4.1-4.1.12 (1997).
46. Perfetto SP, Ambrozak D, Nguyen R, Chattopadhyay P, Roederer M. Quality assurance for polychromatic fow cytometry Nat. Protoc 1(3), 1522-1530 (2006).
47. Saski DT, Maecker H, Trotter J. Establishing optimum baseline PMT setting gain to maximize resolution on BD Bioscience digital cytometers. BD Bioscience Application Note. Part No. 23-8389-00 (2005).
48. CLIA Standards, 42 CFR Part 493, Subpart K, Standard: Control procedures. 493.1256 (2005).
49. CLIA Standards, 42 CFR Part 493, Subpart K, Standard: Corrective actions. 493.1282 (2005).
50. Berte LM, Woodcock SM, Arendash E, Azar M, Rabinovitch A, Stokeld TD. Approved Guideline-Second Edition. Training and Competence Assessment. Clinical and Laboratory Standards Institute (Volume 24) GP21-A2 (2004).
51. CLIA Standards, 42 CFR Part 493, Subpart J, Standard: Retention requirements. 493.1105 (2005).
52. Mountain PJ, Knafel AJ, Butch SH, Dunka L, Markin RS, O'Bryan D. Approved Guideline Second Edition. Laboratory instruments and data management systems: design of software user interfaces and end-user software systems validation operation and monitoring. Clinical and Laboratory Standards Institute (23) GP19-A2 (2003).
53. CLIA Standards, 42 CFR Part 493, Subpart K, Standard: Test report. 493.1291 (2005).
54. Lee JA, Spidlen J, Boyce K et al. MIFlowCyt: the minimum information about a fow cytometry experiment. Cytometry 73A, 926-930 (2008).
55. Spidlen J, Leif RC, Moore W et al. Gating-ML: XML-based gating descriptions in fow cytometry. Cytometry 73A, 1151-1157 (2008).
56. Qian Y, Tchuvatkina O, Spidlen J et al. FuGEFlow: data model and markup language for fow cytometry. BMC Bioinformatics 10, 184 (2009).