ADME of biologics-what have we learned from small molecules?

AAPS Journal

Volumn 14, Issue 3, 2012, Pages 410-419

  Prueksaritanont, Thomayant ^a   Tang, Cuyue ^b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b EnVivo Pharmaceuticals   (United States)

Author keywords

ADME; biologics; drug discovery and development; large molecules; small molecules

Indexed keywords

AMYLOID BETA PROTEIN ANTIBODY; CYTOCHROME P450; DRUG METABOLITE; MONOCLONAL ANTIBODY; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR ALPHA AGONIST; PEROXISOME PROLIFERATOR ACTIVATED RECEPTOR GAMMA AGONIST; SUVOREXANT;

BIOTRANSFORMATION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG POTENCY; DRUG PROTEIN BINDING; DRUG RESEARCH; DRUG STRUCTURE; HISTORY OF MEDICINE; HUMAN; INSOMNIA; ISOMERIZATION; MOLECULAR BIOLOGY; NONHUMAN; REVIEW;

BIOLOGICAL AGENTS; DRUG DISCOVERY;

EID: 84862759363     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9353-6     Document Type: Review

References (62)

1. JA DiMasi L Feldman A Seckler A Wilson 2010 Trends in risks associated with new drug development: success rates for investigational drugs Clin Pharmacol Ther 87 272 277 20130567 10.1038/clpt.2009.295 1:STN:280: DC%2BC3c7htFaquw%3D%3D
2. KI Kaitin MA DiMasi 2011 Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009 Clin Pharmacol Ther 89 183 188 21191382 10.1038/clpt.2010.286 1:STN:280:DC%2BC3M7ivFKisA%3D%3D
3. TA Baillie 2008 Metabolism and toxicity of drugs. Two decades of progress in industrial drug metabolism Chem Res Toxicol 21 129 137 18052111 10.1021/tx7002273
4. JH Lin 2009 Pharmacokinetics of biotech drugs: peptides, proteins and monoclonal antibodies Curr Drug Metab 10 661 691 19702530 10.2174/ 138920009789895499 1:CAS:528:DC%2BC3cXhsFKlu70%3D
5. TA Waldmann 2003 Immunotherapy: past present and future Nat Med 9 269 277 12612576 10.1038/nm0303-269 1:CAS:528:DC%2BD3sXhsFGgs78%3D
6. SM Paul DS Mytelka CT Dunwiddie CC Persinger BH Munos SR Lindborg, et al. 2010 How to improve R&D productivity: the pharmaceutical industry's grand challenge Nat Rev Drug Discov 9 203 214 20168317 1:CAS:528:DC%2BC3cXitFemsbg%3D
7. I Kola J Landis 2004 Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 3 711 715 15286737 10.1038/nrd1470 1:CAS:528:DC%2BD2cXmtVOhtLs%3D
8. NS Sung WF Crowley Jr M Genel P Salber L Sandy LM Sherwood, et al. 2003 Central challenges facing the national clinical research enterprise JAMA 289 1278 1287 12633190 10.1001/jama.289.10.1278
9. M MacCoss TA Baillie 2004 Organic chemistry in drug discovery Science 303 1810 1813 15031494 10.1126/science.1096800 1:CAS:528:DC%2BD2cXitFehu78%3D
10. JH Lin AYH Lu 1997 Role of pharmacokinetics and metabolism in drug discovery and development Pharmacol Rev 49 403 449 9443165 1:CAS:528: DyaK1cXjslSrtQ%3D%3D
11. JH Lin 1995 Species similarities and differences in pharmacokinetics Drug Metab Dispos 23 1008 1021 8654187 1:CAS:528:DyaK2MXovFGksbw%3D
12. C Tang T Prueksaritanont 2010 Use of in vivo animal models to assess pharmacokinetic drug-drug Interactions Pharm Res 27 1772 1787 20428930 10.1007/s11095-010-0157-z 1:CAS:528:DC%2BC3cXltlentbs%3D
13. LC Wienkers TG Heath 2004 Predicting in vivo drug interactions from in vitro drug discovery data Nat Rev Drug Discov 4 825 833 10.1038/nrd1851
14. FP Guengerich 2006 Cytochrome P450s and other enzymes in drug metabolism and toxicity AAPS J 8 E101 E111 16584116 10.1208/aapsj080112 1:CAS:528:DC%2BD28Xks1Kks70%3D
15. RW Estabrook 2003 A passion for P450s (remembrances of the early history of research on cytochrome P450) Drug Metab Dispos 31 1461 1473 14625342 10.1124/dmd.31.12.1461 1:CAS:528:DC%2BD3sXpt1Kgs7c%3D
16. JH Lin AYH Lu 1998 Inhibition and induction of cytochrome P450 and the clinical implications Clin Pharmacokinet 5 361 390 10.2165/00003088-199835050- 00003
17. PK Honig DC Wortham K Zamani DP Conner JC Mullin LR Cantilena 1993 Terfenadine-ketoconazole interaction: pharmacokinetic and electrocardiographic consequences J Am Med Assoc 269 1513 1518 10.1001/jama.1993.03500120051025 1:CAS:528:DyaK3sXktF2qt7c%3D
18. D Schmassmann-Suhijar R Bullingham R Gasser J Schmutz WE Haefeli 1998 Rhabdomyolysis due to interaction of simvastatin with mibefradil Lancet 351 1929 1930 9654265 10.1016/S0140-6736(05)78613-X 1:STN:280:DyaK1czhs1ygtQ%3D%3D
19. T Prueksaritanont B Ma C Tang Y Meng C Assang P Lu, et al. 1999 Metabolic interactions between mibefradil and HMG-CoA reductase inhibitors: an in vitro investigation with human liver preparations Br J Clin Pharmacol 47 291 298 10215754 10.1046/j.1365-2125.1999.00903.x 1:CAS:528:DyaK1MXisVKiu7c%3D
20. M Ingelman-Sundberg 2001 Implications of polymorphic cytochrome P450-dependent drug metabolism for drug development Drug Metab Dispos 29 570 573 11259354 1:CAS:528:DC%2BD3MXis1KmsLw%3D
21. SF Zhou JP Liu B Chowbay 2009 Polymorphism of human cytochrome P450 enzymes and its clinical impact Drug Metab Rev 41 89 295 19514967 10.1080/03602530902843483 1:CAS:528:DC%2BD1MXnsVags78%3D
22. G Hopfgartner E Bourgogne 2003 Quantitative high-throughput analysis of drugs in biological matrices by mass spectrometry Mass Spectrom Rev 22 195 214 12838545 10.1002/mas.10050 1:CAS:528:DC%2BD3sXmsl2ku78%3D
23. WA Korfmacher 2005 Principles and applications of LC-MS in new drug discovery Drug Discov Today 10 1357 1367 16253874 10.1016/S1359-6446(05)03620-2 1:CAS:528:DC%2BD2MXhtFKmsr%2FL
24. J Castro-Perez R Plumb JH Granger L Beattie K Joncour A Wright 2005 Increasing throughput and information content for in vitro drug metabolism experiments using ultra-performance liquid chromatography coupled to a quadrupole time-of-flight mass spectrometer Rapid Commun Mass Spectrom 19 843 848 15723446 10.1002/rcm.1859 1:CAS:528:DC%2BD2MXitl2ktro%3D
25. WA Korfmacher 2006 Use of mass spectrometry for drug metabolism studies Curr Drug Metab 7 455 563 10.2174/138920006777697945 1:CAS:528: DC%2BD28XmtVajtLo%3D
26. R Plumb J Castro-Perez J Granger I Beattie K Joncour A Wright 2004 Ultra-performance liquid chromatography coupled to quadrupole-orthogonal time-of-flight mass spectrometry Rapid Commun Mass Spectrom 18 2331 2337 15384155 10.1002/rcm.1627 1:CAS:528:DC%2BD2cXot1Cmsbg%3D
27. CD Cox MJ Breslin DB Whitman JD Schreier GB McGaughey MJ Bogusky, et al. 2010 Discovery of the dual orexin receptor antagonist [(7R)-4-(5-chloro-1,3- benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl) phenyl]methanone (MK-4305) for the treatment of insomnia J Med Chem 53 5320 5332 20565075 10.1021/jm100541c 1:CAS:528:DC%2BC3cXnvVegsrw%3D
28. KA Riffel MA Polinko HC Song RK Rippley MW Lo 2004 Quantitative determination of a novel insulin sensitizer and its para-hydroxylated metabolite in human plasma by LC-MS/MS J Pharm Biomed Anal 35 523 534 15137977 10.1016/j.jpba.2004.01.004 1:CAS:528:DC%2BD2cXjvVCjtL8%3D
29. SM Huang JM Strong L Zhang KS Reynolds S Nallani R Temple, et al. 2008 New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process J Clin Pharmacol 48 662 670 18378963 10.1177/0091270007312153 1:CAS:528:DC%2BD1cXns1Kitr4%3D
30. S Girish SW Martin MC Peterson LK Zhang H Zhao J Balthasar, et al. 2011 AAPS workshop report: strategies to address therapeutic protein-drug interactions during clinical development AAPS J 13 405 416 21630127 10.1208/s12248-011-9285-6 1:CAS:528:DC%2BC3MXpsFKjur4%3D
31. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Guidance for Industry Drug Interaction Studies -Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations, Draft Guidance, February 2012.
32. JH Lin 2007 Transporter-mediated drug interactions: clinical implications and in vitro assessment Expert Opin Drug Metab Toxicol 3 81 92 17269896 10.1517/17425255.3.1.81 1:CAS:528:DC%2BD2sXhtFGlu74%3D
33. D Bumbaca A Wong E Drake AE Reyes 2nd BC Lin JP Stephan, et al. 2011 Highly specific off-target binding identified and eliminated during the humanization of an antibody against FGF receptor 4 mAbs 3 376 386 21540647 10.4161/mabs.3.4.15786
34. W Wang P Lu Y Fang L Hamuro T Pittman B Carr, et al. 2011 Monoclonal antibodies with identical Fc sequences can bind to FcRn differentially with pharmacokinetic consequences Drug Metab Dispos 39 1469 1477 21610128 10.1124/dmd.111.039453 1:CAS:528:DC%2BC3MXhs1ekurzI
35. W Wang T Prueksaritanont 2010 Prediction of human clearance of therapeutic proteins: simple allometric scaling method revisited Biopharm Drug Dispos 31 253 263 20437464
36. Y Vugmeyster P Szklut D Wensel J Ross X Xu M Awwad, et al. 2011 Complex pharmacokinetics of a humanized antibody against human amyloid Beta Peptide, anti-abeta ab2, in nonclinical species Pharm Res 28 1696 1706 21424161 10.1007/s11095-011-0405-x 1:CAS:528:DC%2BC3MXjsFelsrs%3D
37. WP Burmeister AH Huber PJ Bjorkman 1994 Crystal structure of the complex of rat neonatal Fc receptor with Fc Nature 372 379 383 7969498 10.1038/372379a0 1:CAS:528:DyaK2MXitlOrtrw%3D
38. RP Junghans CL Anderson 1996 The protection receptor for IgG catabolism is the beta(2)-microglobulin-containing neonatal intestinal transport receptor Proc Natl Acad Sci U S A 93 5512 5516 8643606 10.1073/pnas.93.11.5512 1:CAS:528:DyaK28Xjt1Ojsb8%3D
39. V Ghetie JG Hubbard JK Kim MF Tsen YF Lee ES Ward 1996 Abnormally short serum half-lives of IgG in beta 2-microglobulin-deficient mice Eur J Immunol 26 690 696 8605939 10.1002/eji.1830260327 1:CAS:528:DyaK28XhvVGntLg%3D
40. EJ Israel DF Wilsker KC Hayes D Schoenfeld NE Simister 1996 Increased clearance of IgG in mice that lack beta(2)-microglobulin: possible protective role of FcRn Immunology 89 573 578 9014824 10.1046/j.1365-2567.1996.d01-775.x 1:CAS:528:DyaK2sXlsV2m
41. JW Lee M Kelley LE King J Yang H Salimi-Moosavi MT Tang, et al. 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 21240643 10.1208/s12248-011-9251-3 1:CAS:528:DC%2BC3MXhsFWhu7Y%3D
42. European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP). Draft Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins. July 2005.
43. C Tang T Prueksaritanont 2011 Theoretical analysis of interplay of therapeutic protein rug and circulating soluble target: Temporal profiles of 'free' and 'total' drug and target Pharm Res 28 2447 2457 21614635 10.1007/s11095-011-0471-0 1:CAS:528:DC%2BC3MXmsFGgtbk%3D
44. E Ezan M Dubois F Becher 2009 Bioanalysis of recombinant proteins and antibodies by mass spectrometry Analyst 134 825 834 19381370 10.1039/b819706g 1:CAS:528:DC%2BD1MXkslartrw%3D
45. MP Hall C Gegg K Walker C Spahr R Ortiz V Patel, et al. 2010 Ligand-binding 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 12 576 585 20625864 10.1208/s12248-010-9218-9 1:CAS:528:DC%2BC3cXhsFCqsbbK
46. Campbell JC Yves Le Blanc 2011 Peptide and protein drug analysis by MS: challenges and opportunities for the discovery environment Bioanalysis 3 645 657 21417733 10.4155/bio.11.31 1:CAS:528:DC%2BC3MXjs1Wqsr0%3D
47. AL Nelson E Dhimolea JM Reichert 2010 Development trends for human monoclonal antibody therapeutics Nat Rev Drug Discov 9 767 774 20811384 10.1038/nrd3229 1:CAS:528:DC%2BC3cXhtFSisLnO
48. A Yamaguchi K Usami K Masuda 2011 Current technological development of antibody therapeutics Immun Endoc Metab Agents Med Chem 11 21 32 10.2174/187152211794519458 1:CAS:528:DC%2BC3MXjtFahsL8%3D
49. LI Jing ZHU Zhenping 2010 Research and development of next generation of antibody-based therapeutics Acta Pharmacol Sin 31 1198 1207 10.1038/aps.2010.120
50. A Beck O Cochet T Wurch 2010 GlycoFi's technology to control the glycosylation of recombinant therapeutic proteins Expert Opin Drug Discov 5 95 111 10.1517/17460440903413504 1:CAS:528:DC%2BD1MXhs1aqtLnN
51. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), The CDER Science Prioritization and Review Committee (SPaRC). Identifying CDER's Science and Research Needs Report, July 2011.
52. S Aggarwal 2011 What's fueling the biotech engine-2010 to 2011 Nat Biotech 29 1083 1089 10.1038/nbt.2060 1:CAS:528:DC%2BC3MXhs12gsbzE
53. DE Mager E Wyska WJ Jusko 2003 Diversity of mechanism-based pharmacodynamic models Drug Metab Dispos 31 510 518 12695336 10.1124/dmd.31.5.510 1:CAS:528:DC%2BD3sXjt1Ggtrg%3D
54. T Prueksaritanont JH Lin TA Baillie 2006 Complicating factors in safety testing of drug metabolites: kinetic differences between generated and preformed metabolites Toxicol Appl Pharmacol 217 143 152 17055014 10.1016/j.taap.2006.08. 009 1:CAS:528:DC%2BD28Xht1SmsLbP
55. Wang W, Chen N, Shen X, Cunningham P, Fauty S, Michel K, et al. Lymphatic transport and catabolism of therapeutic proteins following subcutaneous administration to rats and dogs. Drug Metab Dispos. Published ahead of print February 10, 2012. doi: 10.1124/dmd.111.043604.
56. ED Lobo RJ Hansen JP Balthasar 2004 Antibody pharmacokinetics and pharmacodynamics J Pharm Sci 93 2645 2668 15389672 10.1002/jps.20178 1:CAS:528:DC%2BD2cXpvV2isLk%3D
57. W Wang EQ Wang JP Balthasar 2008 Monoclonal antibody pharmacokinetics and pharmacodynamics Clin Pharmacol Ther 84 548 558 18784655 10.1038/clpt.2008.170 1:CAS:528:DC%2BD1cXht1OisLvM
58. Y Vugmeyster D Defranco P Szklut Q Wang X Xu 2010 Biodistribution of [(125)I]-labeled therapeutic proteins: application in protein drug development beyond oncology J Pharm Sci 99 1028 1045 19569059 1:CAS:528:DC%2BD1MXhsF2jsL3J
59. WF Dall'Acqua PA Kiener H Wu 2006 Properties of human IgG1s engineered for enhanced binding to the neonatal Fc receptor (FcRn) J Biol Chem 281 23514 23524 16793771 10.1074/jbc.M604292200
60. T Igawa H Tsunoda T Tachibana A Maeda F Mimoto C Moriyama, et al. 2010 Reduced elimination of IgG antibodies by engineering the variable region Protein Eng Des Sel 23 385 392 20159773 10.1093/protein/gzq009 1:CAS:528: DC%2BC3cXks1Gqtrw%3D
61. W Wang J Vlasak Y Li P Pristatsky Y Fang T Pittman, et al. 2011 Impact of methionine oxidation in human IgG1 Fc on serum half-life of monoclonal antibodies Mol Immunol 48 860 866 21256596 10.1016/j.molimm.2010.12.009 1:CAS:528:DC%2BC3MXitFagt78%3D
62. D Filpula 2007 Antibody engineering and modification technologies Biomol Eng 24 201 215 17466589 10.1016/j.bioeng.2007.03.004 1:CAS:528: DC%2BD2sXls1SjsLg%3D