Analytical assay platforms for soluble target engagement biomarkers: Old favorites and emerging technologies

Bioanalysis

Volumn 5, Issue 23, 2013, Pages 2919-2931

  Goodman, Joanne ^a   Agoram, Balaji ^a  

^a MEDIMMUNE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; RHEUMATOID FACTOR;

ANALYTIC METHOD; ANTIBODY DETECTION; ANTIGEN DETECTION; ARTICLE; AUTOMATION; BINDING AFFINITY; DECISION MAKING; ENZYME LINKED IMMUNOSORBENT ASSAY; IMMUNOASSAY; IMMUNOGENICITY; IMMUNOHISTOCHEMISTRY; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MICROFLUIDICS; PROCESS DEVELOPMENT; SENSITIVITY ANALYSIS;

ANIMALS; BIOLOGICAL MARKERS; DRUG DISCOVERY; ENZYME-LINKED IMMUNOSORBENT ASSAY; EQUIPMENT DESIGN; HUMANS; IMMUNOASSAY;

EID: 84890320140     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.262     Document Type: Article

References (19)

1. Roskos L, Schneider A, Vainshtein I et al. PK-PD modelling of protein drugs: Implications in assay development. Bioanalysis 3(6), 659-675 (2011
2. Lee JW, Salimi-Moosavi H. Bioanalysis of target biomarker and PK/PD relevancy during the development of biotherapeutics. Bioanalysis 4(20), 2513-2523 (2012
3. Deng R, Lyer S, Theil F, Mortensen D, Fielder P, Prabhu S. Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data. MAbs 3(1), 61-66 (2011
4. White J, Golob M, Sailstad J. Understanding and mitigating impact of immunogenicity on pharmacokinetic assays. Bioanalysis 3(16), 1799-1803 (2011
5. Boscato LM, Stuart MC. Heterophilic antibodies: A problem for all immunoassays. Clin. Chem. 31(1), 27-33 (1988
6. 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
7. Bartels EM, Wätjen IF, Andersen EL, Danneskiold-Samsoe B, Bliddal H, Ribel-Madsen S. Rheumatoid factor and its interference with cytokine measurements: Problems and solutions. Arthritis 741071-741178 (2011
8. Waage P, Guldberg CM. Studies concerning affinity. Forhandlinger: Videnskabs-Selskabet i Christiania. 35 (1864
9. Lee JW, Kelly M, King LE 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
10. Avrameas S, Guilbert B. Enzyme-immunoassay for the measurement of antigens using peroxidase conjugates. Biochimie 54, 837-842 (1972
11. Engvall E, Pelmann P. Enzyme-linked immunosorbent assay, ELISA. II. Quantitative assay of protein antigen, immunoglobulin G, by means of enzyme-labelled antigen and antibody-coated tubes. Immunochemistry 8, 874-879 (1971
12. Uotila M, Rusolanti E, Engvall E. Two-site sandwich enzyme immunoassay with monoclonal antibodies to human alpha-fetoprotein. J. Immunol. Methods 42, 11-15 (1981
13. Schuurs AHWM, van Weemen BK. Enzyme-immunoassay: A powerful analytical tool. J. Immunoassay 1(2), 229-249 (1980
14. Wu JT. Quantitative Immunoassay: A Practical Guide for Assay Establishment, Troubleshooting, and Clinical Application. AACC Press, Washington, DC, USA 255 (2000
15. Wild D. The Immunoassay Handbook. Elsevier, Oxford, UK (2005
16. Yohrling J. Ligand-binding assays: Risk of using a platform supported by a single vendor. Bioanalysis 1(3), 629-636 (2009
17. Allinson J. Automated immunoassay equipment platforms for analytical support of pharmaceutical and biopharmaceutical development. Bioanalysis 3(24), 2803-2816 (2011
18. European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on Bioanalytical Method Validation. European Medicines Agency, London, UK (2011
19. Tate J, Ward G. Interferences in immunoassay. Clin. Biochem. Rev. 25(2), 105-120 (2004