Validation and life-cycle management of a quantitative ligand-binding assay for the measurement of Nulojix®, a CTLA-4-Fc fusion protein, in renal and liver transplant patients

Bioanalysis

Volumn 4, Issue 10, 2012, Pages 1215-1226

  Myler, Heather A ^a   Phillips, Kelli R ^b   Dong, Huijin ^a   Tabler, Edward ^b   Shaikh, Mehmooda ^a   Coats, Valarie ^b   Hay, Laura ^b   Tacey, Richard ^b   Stouffer, Bruce ^a  

^a BRISTOL MYERS SQUIBB   (United States)

^b Pharmaceutical Product Development   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BELATACEPT; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4 ANTIBODY;

ACCURACY; ANALYTIC METHOD; ANALYTICAL ERROR; ARTICLE; ASCITES; AUTOMATION; BINDING ASSAY; BIOTINYLATION; DOUBLE ANTIBODY SANDWICH ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; KIDNEY TRANSPLANTATION; LIVER TRANSPLANTATION; QUANTITATIVE LIGAND BINDING ASSAY; URINE; VALIDATION PROCESS;

ADULT; ANTIBODIES, MONOCLONAL; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; IMMUNOCONJUGATES; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; LIVER TRANSPLANTATION; MALE; MONITORING, PHYSIOLOGIC; RECOMBINANT FUSION PROTEINS; REGRESSION ANALYSIS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 84861874637     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.12.79     Document Type: Article

References (30)

1. Dong H, Freebern WJ, Wang V et al. Quantitative determination of Nulojix® in cynomolgous monkey serum, cerebrospinal fluid, and brain tissue to support a 1-month exploratory blood-brain barrier (BBB) permeability study. Presented at: AAPS National Biotechnology Conference. San Francisco, CA, USA, 16-18 May 2011.
2. Findlay JWA, Smith WC, Lee JW et al. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J. Pharm. Biomed. Anal. 21, 1249-1273 (2000
3. DeSilva B, Smith W, Weiner R et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 20(11), 1885-1900 (2003
4. Kelley M, DeSilva B. Key elements of bioanalytical method validation for macromolecules. Aaps J. 9(2), E156-E163 (2007
5. Smolec J, DeSliva B, Smith W et al. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharm. Res. 22(9), 1425-1431 (2005
6. Lee J, Ma H. Specificity and selectivity evaluations of ligand-binding assay of protein therapeutics against concomitant drugs and related endogenous proteins. Aaps J. 9(2), E164-E170 (2007
7. Viswanathan CT. Incurred sample reanalysis: a global transformation. Bioanalysis 3(23), 2601-2602 (2011
8. Fast DM, Kelley M, Viswanathan CT et al. Workshop report and follow-up - AAPS Workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples - implications of Crystal City recommendations. Aaps J. 11(2), 238-241 (2009
9. Sailstad JM, Salfen BE, Bowsher RR. Incurred sample reanalysis: failures in macromolecule analysis - insight into possible causes. Bioanalysis 3(9), 1001-1006 (2011
10. Nulojix® prescribing information. Bristol-Myers Squibb, Princeton, NJ, USA (2010
11. Shen J, Block A, Townsend R et al. Pharmacokinetics, pharmacodynamics, and immunogenicity of Nulojix® in renal transplant patients. Presented at: The Transplantation Society Meeting. Vancouver, Canada, 15-19 August 2010.
12. Rostaing L, Pearson T, Medina Pestana J et al. Pharmacokinetics of mycophenolic acid (MPA) with belatacept or cyclosporine (CsA)-based regimens. Presented at: The American Transplant Congress. San Diego, CA, USA, 1-5 May 2010.
13. Shen J, Summerill R, Shen Y et al. Safety and pharmacokinetics of belatacept after a single escalating intravenous administration in healthy subjects. Presented at: The American College of Clinical Pharmacology. Baltimore, MA, USA, 12 September 2009.
14. Vincenti F, Charpentier B, Vanrenterghem Y et al. A Phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT Study).Am. J. Transplan. 10, 535-546 (2010
15. Shen J, McGirr N, Shen Y et al. Belatacept: safety, linear pharmacokinetics, and dose proportionality in a first-in-human study in healthy subjects. Presented at: The American College of Clinical Pharmacology. Baltimore, MA, USA, 12 September 2009.
16. Lee JW, Wang Y-M, Moxness M, DeSilva B. Bioanalytical considerations in the comparability assessment of biotherapeutics. Bioanalysis 3(6), 613-622 (2011
17. O'Hara DM, Theobald V, Clements Egan A. Ligand binding assays in the 21st century: recommendations for characterization and supply of critical reagents. Aaps J. 14(2), 316-328 (2012
18. Rup B, O'Hara D. Critical ligand binding reagent preparation/selection: when specificity depends on reagents. Aaps J. 9(2), E148-E155 (2007
19. Pandya K, Ray CA, L Brunner et al. Strategies to minimize variability and bias associated with manual pipetting in ligand-binding assays to assure data quality of protein therapeutics. J. Pharm. Biomed. Anal. 53, 623-630 (2010
20. Myler H, Given A, Kolz K et al. Biotherapeutic bioanalysis: a multi-indication case study review. Bioanalysis 3(6), 623-624 (2011
21. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Bioanalytical Method Validation. Rockville, MD, USA (2001
22. European Medicines Agency. Guideline on Bioanalytical Method Validation. London, UK (2011
23. Nowatzke B, Rogers K, Wells E et al. Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs. Bioanalysis 3(5), 509-521 (2011
24. Ray CA, Patel V, Shih J et al. Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins. J. Pharm. Biomed. Anal. 49(2), 311-318 (2009
25. Myler HA, McVay S, Kratzsch J. Troubleshooting PEG-hGH detection supporting pharmacokinetic evaluation in growth hormone deficient patients. J. Pharm. Tox. Methods 61, 92-97 (2010
26. Lee J, Kelley M, King F et al. Bioanalytical approaches to quantify 'total' and 'free' therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. Aaps J. 13(1), 99-110 (2011
27. Hall MP, Gegg C, Walker K et al. Ligandbinding mass spectrometry to study biotransformation of fusion protein drugs and guide immunoassay development: strategic approach and application to peptibodies targeting the thrombopoietin receptor. Aaps J. 12(4), 576-585 (2010
28. Ocaña MF, Neubert H. An immunoaffinity liquid chromatography-tandem mass spectrometry assay for the quantitation of matrix metalloproteinase 9 in mouse serum. Anal. Biochem. 399, 202-210 (2010
29. Zheng O, Furlong MT, Wu S et al. Pellet digestion: a simple and efficient sample preparation technique for LC-MS/MS quantification of large therapeutic proteins in plasma. Bioanalysis 4(1), 17-28 (2012
30. Ji QC, Rodila R, El-Shourbagy TA. A sample preparation process for LC-MS/MS analysis of total protein drug concentrations in monkey plasma samples with antibody. J. Chromat. B. 847, 133-141 (2007