Aptamers as a sensitive tool to detect subtle modifications in therapeutic proteins

PLoS ONE

Volumn 7, Issue 2, 2012, Pages

  Zichel, Ran ^a,b   Chearwae, Wanida ^a   Pandey, Gouri Shankar ^a   Golding, Basil ^a   Sauna, Zuben E ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b ISRAEL INSTITUTE FOR BIOLOGICAL RESEARCH   (Israel)

Author keywords

[No Author keywords available]

Indexed keywords

APTAMER; THROMBIN; EPITOPE; MONOCLONAL ANTIBODY; PEPTIDE APTAMER; PROTEIN;

AMINO ACID SEQUENCE; ARTICLE; CONFORMATIONAL TRANSITION; CONTROLLED STUDY; DRUG STRUCTURE; ENZYME LINKED IMMUNOSORBENT ASSAY; HIGH TEMPERATURE PROCEDURES; PROTEIN BINDING; PROTEIN DETERMINATION; PROTEIN FUNCTION; PROTEIN MODIFICATION; PROTEIN SYNTHESIS; QUALITY CONTROL; STRUCTURE ANALYSIS; ANIMAL; CATTLE; CHEMISTRY; CODON; ENZYME SPECIFICITY; GENETIC PROCEDURES; HUMAN; INTERFEROMETRY; KINETICS; METHODOLOGY; PROTEIN CONFORMATION; PROTEIN PROCESSING; SENSITIVITY AND SPECIFICITY; TEMPERATURE;

ANIMALS; ANTIBODIES, MONOCLONAL; APTAMERS, PEPTIDE; BIOSENSING TECHNIQUES; CATTLE; CODON; ENZYME-LINKED IMMUNOSORBENT ASSAY; EPITOPES; HUMANS; INTERFEROMETRY; KINETICS; PROTEIN BINDING; PROTEIN CONFORMATION; PROTEIN PROCESSING, POST-TRANSLATIONAL; PROTEINS; SENSITIVITY AND SPECIFICITY; SUBSTRATE SPECIFICITY; TEMPERATURE; THROMBIN;

EID: 84857579550     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0031948     Document Type: Article

References (42)

1. Belsey MJ, Harris LM, Das RR, Chertkow J, (2006) Biosimilars: initial excitement gives way to reality. Nat Rev Drug Discov 5: 535-536.
2. Rathore AS, (2009) Follow-on protein products: scientific issues, developments and challenges. Trends Biotechnol 27: 698-705.
3. Rathore AS, Winkle H, (2009) Quality by design for biopharmaceuticals. Nat Biotechnol 27: 26-34.
4. Schellekens H, (2004) When biotech proteins go off-patent. Trends Biotechnol 22: 406-410.
5. Anonymous, (2006) Guideline on similar biological medicinal products conataining biotechnology-derived proteins as active substance. European Medicines Agency.
6. Kozlowski S, Woodcock J, Midthun K, Sherman RB, (2011) Developing the nation's biosimilars program. N Engl J Med 365: 385-388.
7. Schellekens H, Moors E, (2010) Clinical comparability and European biosimilar regulations. Nat Biotechnol 28: 28-31.
8. Roger SD, (2010) Biosimilars: current status and future directions. Expert Opin Biol Ther 10: 1011-1018.
9. Chirino AJ, Mire-Sluis A, (2004) Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol 22: 1383-1391.
10. Rockberg J, Lofblom J, Hjelm B, Uhlen M, Stahl S, (2008) Epitope mapping of antibodies using bacterial surface display. Nat Methods 5: 1039-1045.
11. Barlow DJ, Edwards MS, Thornton JM, (1986) Continuous and discontinuous protein antigenic determinants. Nature 322: 747-748.
12. Pizzi E, Cortese R, Tramontano A, (1995) Mapping epitopes on protein surfaces. Biopolymers 36: 675-680.
13. Tombelli S, Mascini M, (2009) Aptamers as molecular tools for bioanalytical methods. Curr Opin Mol Ther 11: 179-188.
14. Kessler CM, Ortel TL, (2009) Recent developments in topical thrombins. Thromb Haemost 102: 15-24.
15. Lomax C, Traub O, (2009) Topical Thrombins: Benefits and Risks. Pharmacotherapy 29: 8S-12S.
16. Dichtelmuller H, Rudnick D, Breuer B, Kotitschke R, Kloft M, et al. (1996) Improvement of virus safety of a S/D-treated factor VIII concentrate by additional dry heat treatment at 100 degrees C. Biologicals 24: 125-130.
17. Raut S, Di Giambattista M, Bevan SA, Hubbard AR, Barrowcliffe TW, et al. (1998) Modification of factor VIII in therapeutic concentrates after virus inactivation by solvent-detergent and pasteurisation. Thromb Haemost 80: 624-631.
18. Tasset DM, Kubik MF, Steiner W, (1997) Oligonucleotide inhibitors of human thrombin that bind distinct epitopes. J Mol Biol 272: 688-698.
19. Macaya RF, Schultze P, Smith FW, Roe JA, Feigon J, (1993) Thrombin-binding DNA aptamer forms a unimolecular quadruplex structure in solution. Proc Natl Acad Sci U S A 90: 3745-3749.
20. Tsiang M, Jain AK, Dunn KE, Rojas ME, Leung LL, et al. (1995) Functional mapping of the surface residues of human thrombin. J Biol Chem 270: 16854-16863.
21. Thrombin-JMI package insert (2007) Jones Pharma Incorporated, Bristol, VA.
22. Evithrom Package Insert (2007) J&J Wound Management, Somerville, NJ.
23. Recothrom Package Insert (2007) Zymogenetics Inc, Seatle, WA.
24. Doria C, Fischer CP, Wood CG, Li PM, Marra S, et al. (2008) Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery. Curr Med Res Opin 24: 785-794.
25. Chapman WC, Singla N, Genyk Y, McNeil JW, Renkens KL Jr, et al. (2007) A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg 205: 256-265.
26. Peerlinck K, Arnout J, Di Giambattista M, Gilles JG, Laub R, et al. (1997) Factor VIII inhibitors in previously treated haemophilia A patients with a double virus-inactivated plasma derived factor VIII concentrate. Thromb Haemost 77: 80-86.
27. Dawes J, James K, Micklem LR, Pepper DS, Prowse CV, (1984) Monoclonal antibodies directed against human alpha-thrombin and the thrombin-antithrombin III complex. Thromb Res 36: 397-409.
28. Modesti PA, Gamberi T, Bazzini C, Borro M, Romano SM, et al. (2009) Response of serum proteome in patients undergoing infrarenal aortic aneurysm repair. Anesthesiology 111: 844-854.
29. Byeon JY, Limpoco FT, Bailey RC, (2010) Efficient bioconjugation of protein capture agents to biosensor surfaces using aniline-catalyzed hydrazone ligation. Langmuir 26: 15430-15435.
30. Concepcion J, Witte K, Wartchow C, Choo S, Yao D, et al. (2009) Label-free detection of biomolecular interactions using BioLayer interferometry for kinetic characterization. Comb Chem High Throughput Screen 12: 791-800.
31. Schellekens H, (2005) Factors influencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant 20: 3-9.
32. Shankar G, Pendley C, Stein KE, (2007) A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat Biotechnol 25: 555-561.
33. Schoenecker JG, Johnson RK, Fields RC, Lesher AP, Domzalski T, et al. (2003) Relative purity of thrombin-based hemostatic agents used in surgery. J Am Coll Surg 197: 580-590.
34. Carothers JM, Oestreich SC, Davis JH, Szostak JW, (2004) Informational complexity and functional activity of RNA structures. J Am Chem Soc 126: 5130-5137.
35. Ruigrok VJ, Levisson M, Eppink MH, Smidt H, van der Oost J, (2011) Alternative affinity tools: more attractive than antibodies? Biochem J 436: 1-13.
36. Jhaveri S, Rajendran M, Ellington AD, (2000) In vitro selection of signaling aptamers. Nat Biotechnol 18: 1293-1297.
37. Iliuk AB, Hu L, Tao WA, (2011) Aptamer in bioanalytical applications. Anal Chem 83: 4440-4452.
38. Soukup GA, Breaker RR, (1999) Nucleic acid molecular switches. Trends Biotechnol 17: 469-476.
39. Famulok M, (2005) Allosteric aptamers and aptazymes as probes for screening approaches. Curr Opin Mol Ther 7: 137-143.
40. Rentmeister A, Mayer G, Kuhn N, Famulok M, (2007) Conformational changes in the expression domain of the Escherichia coli thiM riboswitch. Nucleic Acids Res 35: 3713-3722.
41. Vinkenborg JL, Karnowski N, Famulok M, (2011) Aptamers for allosteric regulation. Nat Chem Biol 7: 519-527.
42. Schneider CK, Kalinke U, (2008) Toward biosimilar monoclonal antibodies. Nat Biotechnol 26: 985-990.