Attribution of the discrepancy between ELISA and LC-MS/MS assay results of a PEGylated scaffold protein in post-dose monkey plasma samples due to the presence of anti-drug antibodies

Analytical and Bioanalytical Chemistry

Volumn 402, Issue 3, 2012, Pages 1229-1239

  Wang, Shujie J ^a   Wu, Steven T ^b   Gokemeijer, Jochem ^c   Fura, Aberra ^b   Krishna, Murli ^b   Morin, Paul ^b   Chen, Guodong ^b   Price, Karen ^b   Wang Iverson, David ^d   Olah, Timothy ^b   Weiner, Russell ^e   Tymiak, Adrienne ^b   Jemal, Mohammed ^b  

^a PFIZER INC   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

^c A Bristol Myers Squibb R and D Company   (United States)

^d NONE   (United States)

^e MERCK RESEARCH LABORATORIES   (United States)

Author keywords

ELISA; Free and total drug; Immunogenicity; LC MS MS; Pharmacokinetics; Therapeutic proteins

Indexed keywords

CHEMICAL DETECTION; ELECTROPHORESIS; EPITOPES; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MONOCLONAL ANTIBODIES; PHARMACOKINETICS; SCAFFOLDS (BIOLOGY);

ELISA; FREE AND TOTAL DRUG; IMMUNOGENICITY; LC-MS/MS; THERAPEUTIC PROTEIN;

DRUG DOSAGE;

HAPLORHINI; MACACA FASCICULARIS;

EID: 84856232988     PISSN: 16182642     EISSN: 16182650     Source Type: Journal    
DOI: 10.1007/s00216-011-5527-9     Document Type: Article

References (24)

1. CT Viswanathan S Bansal B Brian AJ DeStefano MJ Rose J Sailstad VP Shah JP Skelly PG Swann R Weiner 2007 Workshop/Conference report-quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays AAPS J 9 E30 E42 10.1208/aapsj0901004 (Pubitemid 46296546)
2. W Wang EQ Wang JP Balthasar 2008 Monoclonal antibody pharmacokinetics and pharmacodynamics Clin Pharmacol Ther 84 548 558 10.1038/clpt.2008.170 1:CAS:528:DC%2BD1cXht1OisLvM
3. OH Brekke I Sandlie 2003 Therapeutic antibodies for human diseases at the dawn of the twenty-first century Nature Review Drug Discovery 2 52 62 10.1038/nrd984 1:CAS:528:DC%2BD3sXntF0%3D (Pubitemid 37361624)
4. M Kelley B DeSilva 2007 Key elements of bioanalytical method validation for macromolecules AAPS J 9 E156 E163 10.1208/aapsj0902017 (Pubitemid 46812967)
5. AS Rosenberg A Worobec 2005 A risk-based approach to immunogenicity concerns of therapeutic protein products. Part 3: effects of manufacturing changes in immunogenicity and the utility of animal immunogenicity studies Biopharm International 18 32 36 (Pubitemid 40486131)
6. G Shankar C Pendley KE Stein 2007 A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs Nat Biotechnol 25 555 561 10.1038/nbt1303 1:CAS:528:DC%2BD2sXkvFWns70%3D (Pubitemid 46834844)
7. E Koren HW Smith E Shores G Shankar D Finco-Kent B Rup YC Barrett V Devanarayan B Gorovits S Gupta T Parish V Quarmby M Moxness SJ Swanson G Taniguchi LA Zuckerman CC Stebbins A Mire-Sluis 2008 Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products J Immunol Methods 333 1 9 10.1016/j.jim.2008.01.001 1:CAS:528:DC%2BD1cXktlWku70%3D
8. F Becher A Pruvost G Clement JC Tabet E Ezan 2006 Quantification of small therapeutic proteins in plasma by liquid chromatography-tandem mass spectrometry: application to an elastase inhibitor EPI-hNE4 Anal Chem 78 2306 2313 10.1021/ac0515531 1:CAS:528:DC%2BD28XhslersLg%3D
9. BA Buscher H Gerritsen I van Schöll NH Cnubben LP Brüll 2007 Quantitative analysis of Tenecteplase in rat plasma samples using LC-MS/MS as an alternative for ELISA J Chromatogr B Analyt Technol Biomed Life Sci 852 631 634 10.1016/j.jchromb.2006.12.053 1:CAS:528:DC%2BD2sXmtVGltrs%3D (Pubitemid 46830103)
10. ST Wu Z Ouyang TV Olah M Jemal 2011 A strategy for liquid chromatography/tandem mass spectrometry based quantitation of PEGylated protein drugs in plasma using plasma protein precipitation with water-miscible organic solvents and subsequent trypsin digestion to generate surrogate peptides for detection Rapid Commun Mass Spectrom 25 281 290 10.1002/rcm.4856 1:CAS:528:DC%2BC3cXhs1ens7jP
11. H Liu AV Manuilov C Chumsae ML Babineau E Tarcsa 2011 Quantitation of a recombinant monoclonal antibody in monkey serum by liquid chromatography-mass spectrometry Anal Chem 414 147 153 1:CAS:528:DC%2BC3MXlvVChsr4%3D
12. JE Prenni Z Shen S Trauger W Chen G Siuzdak 2003 Protein characterization using liquid chromatography desorption ionization on silicon mass spectrometry Spectroscopy 17 693 698 1:CAS:528:DC%2BD2cXhsFant7c%3D (Pubitemid 38010425)
13. Q Lu X Zheng T McIntosh H Davis JF Nemeth C Pendley SL Wu WS Hancock 2009 Development of different analysis platforms with LC-MS for pharmacokinetic studies of protein drugs Anal Chem 81 8715 8723 10.1021/ac901991x 1:CAS:528:DC%2BD1MXhtF2ltLjN
14. O Heudi S Barteau D Zimmer J Schmidt K Bill N Lehmann C Bauer O Kretz 2008 Towards absolute quantification of therapeutic monoclonal antibody in serum by LC-MS/MS using isotope-labeled antibody standard and protein cleavage isotope dilution mass spectrometry Anal Chem 80 4200 4207 10.1021/ac800205s 1:CAS:528:DC%2BD1cXlslOjsL4%3D (Pubitemid 351812775)
15. M Jemal YQ Xia 2006 LC-MS Development strategies for quantitative bioanalysis Curr Drug Metab 7 491 502 10.2174/138920006777697927 1:CAS:528:DC%2BD28XmtVajtLY%3D
16. M Jemal Z Ouyang YQ Xia 2010 Systematic LC-MS/MS bioanalytical method development that incorporates plasma phospholipids risk avoidance, usage of incurred sample and well thought-out chromatography Biomed Chromatogr 24 2 19 10.1002/bmc.1373 1:CAS:528:DC%2BD1MXhsF2jtrfO
17. J Hakimi R Chizzonite DR Luke PC Familletti P Bailon JA Kondas RS Pilson P Lin DV Weber C Spence 1991 Reduced immunogenicity and improved pharmacokinetics of humanized anti-Tac in cynomolgus monkeys J Immunol 147 1352 1359 1:CAS:528:DyaK3MXmt12qu7g%3D
18. WY Hwang J Foote 2005 Immunogenicity of engineered antibodies Methods 36 3 10 10.1016/j.ymeth.2005.01.001 1:CAS:528:DC%2BD2MXjsVegs7o%3D (Pubitemid 40558811)
19. CJ van der Laken AE Voskuyl JC Roos M Stigter van Walsum ER de Groot G Wolbink BA Dijkmans LA Aarden 2007 Imaging and serum analysis of immune complex formation of radiolabelled infliximab and anti-infliximab in responders and non-responders to therapy for rheumatoid arthritis Ann Rheum Dis 66 253 256 10.1136/ard.2006.057406 (Pubitemid 46226064)
20. BN Rehlaender MJ Cho 1998 Antibodies as carrier proteins Pharm Res 15 1652 1656 10.1023/A:1011936007457 1:CAS:528:DyaK1cXnsFSgu7c%3D (Pubitemid 28524572)
21. JW Lee M Kelly LE King J Yang H Salimi-Moosavi MT Tang JF Lu J Kamerud A Ahene H Myler C Rogers 2011 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 99 110 10.1208/s12248-011-9251-3 1:CAS:528:DC%2BC3MXhsFWhu7Y%3D
22. DK Walker 2004 The use of pharmacokinetic and pharmacodynamic data in the assessment of drug safety in early drug development Br J Clin Pharmacol 58 601 608 10.1111/j.1365-2125.2004.02194.x 1:CAS:528:DC%2BD2MXms1SqtA%3D%3D (Pubitemid 39665147)
23. JS Hoos MC Damsten JS de Vlieger JN Commandeur NP Vermeulen WM Niessen H Lingeman 2007 Automated detection of covalent adducts to human serum albumin by immunoaffinity chromatography, on-line solution phase digestion and liquid chromatography-mass spectrometry J Chromatogr B Analyt Technol Biomed Life Sci 859 147 156 10.1016/j.jchromb.2007.09.015 1:CAS:528:DC%2BD2sXht12ns7vO (Pubitemid 350046443)
24. M Dubois F Becher A Herbet E Ezan 2007 Immuno-mass spectrometry assay of EPI-HNE4, a recombinant protein inhibitor of human elastase Rapid Commun Mass Spectrom 21 352 358 10.1002/rcm.2844 1:CAS:528:DC%2BD2sXitValsbY%3D (Pubitemid 46212547)