Application of extrinsic fluorescence spectroscopy for the high throughput formulation screening of aluminum-adjuvanted vaccines

Journal of Pharmaceutical Sciences

Volumn 100, Issue 2, 2011, Pages 431-440

  Ausar, Salvador F ^a   Chan, Judy ^a   Hoque, Warda ^a   James, Olive ^a   Jayasundara, Kavisha ^a   Harper, Kevin ^a  

^a DEFENCE RESEARCH AND DEVELOPMENT CANADA   (Canada)

Author keywords

Formulation; High throughput technologies; Stability; Vaccine adjuvants; Vaccines

Indexed keywords

ALUMINUM; ALUMINUM HYDROXIDE; ARGININE; ASPARTIC ACID; BACTERIAL ANTIGEN; BACTERIAL PROTEIN; DIETHANOLAMINE; GLUCOSE; GLUTAMIC ACID; GLYCINE; HISTIDINE; IMMUNOLOGICAL ADJUVANT; LACTOSE; LYSINE; MANNITOL; PNEUMOCOCCAL PROTEIN ANTIGEN A; PNEUMOCOCCAL PROTEIN ANTIGEN B; PNEUMOCOCCAL PROTEIN ANTIGEN C; PROLINE; SORBITOL; STABILIZING AGENT; SUCROSE; TAURINE; TREHALOSE; UNCLASSIFIED DRUG;

ADSORPTION; ANTIGENICITY; ARTICLE; DRUG FORMULATION; DRUG STABILITY; FLUORESCENCE SPECTROSCOPY; HEATING; HIGH THROUGHPUT SCREENING; MELTING POINT; PH; PROCESS OPTIMIZATION; PROTEIN CONFORMATION; THERMOSTABILITY;

EID: 78650570898     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22282     Document Type: Article

References (37)

1. Wilson-Welder JH, Torres MP, Kipper MJ, Mallapragada SK, Wannemuehler MJ, Narasimhan B. 2009. Vaccine adjuvants: Current challenges and future approaches. J Pharm Sci 98:1278-1316.
2. Hem SL, White JL. 1995. Structure and properties of aluminum-containing adjuvants. Pharm Biotechnol 6:249-276.
3. Hogenesch H. 2002. Mechanisms of stimulation of the immune response by aluminum adjuvants. Vaccine 20(Suppl.3):S34-S39.
4. Gupta RK. 1998. Aluminum compounds as vaccine adjuvants. Adv Drug Deliv Rev 32:155-172.
5. Lambrecht BN, Kool M, Willart MA, Hammad H. 2009. Mechanism of action of clinically approved adjuvants. Curr Opin Immunol 21:23-29.
6. Eisenbarth SC, Colegio OR, O'Connor W, Sutterwala FS, Flavell RA. 2008. Crucial role for the Nalp3 inflammasome in the immunostimulatory properties of aluminium adjuvants. Nature 453:1122-1126.
7. McKee AS, Munks MW, MacLeod MK, Fleenor CJ, Van RN, Kappler JW, Marrack P. 2009. Alum induces innate immune responses through macrophage and mast cell sensors, but these sensors are not required for alum to act as an adjuvant for specific immunity. J Immunol 183:4403-4414.
8. al-Shakhshir RH, Regnier FE, White JL, Hem SL. 1995. Contribution of electrostatic and hydrophobic interactions to the adsorption of proteins by aluminium-containing adjuvants. Vaccine 13:41-44.
9. Hem SL, Hogenesch H. 2007. Relationship between physical and chemical properties of aluminum-containing adjuvants and immunopotentiation. Expert Rev Vaccines 6:685-698.
10. Morefield GL, Jiang D, Romero-Mendez IZ, Geahlen RL, Hogenesch H, Hem SL. 2005. Effect of phosphorylation of ovalbumin on adsorption by aluminum-containing adjuvants and elution upon exposure to interstitial fluid. Vaccine 23:1502-1506.
11. Berthold I, Pombo ML, Wagner L, Arciniega JL. 2005. Immunogenicity in mice of anthrax recombinant protective antigen in the presence of aluminum adjuvants. Vaccine 23:1993-1999.
12. Romero MI, Shi Y, HogenEsch H, Hem SL. 2007. Potentiation of the immune response to non-adsorbed antigens by aluminum-containing adjuvants. Vaccine 25:825-833.
13. Volkin DB, Burke CJ, Sanyal G, Middaugh CR. 1996. Analysis of vaccine stability. Dev Biol Stand 87:135-142.
14. Capelle MA, Gurny R, Arvinte T. 2007. High throughput screening of protein formulation stability: Practical considerations. Eur J Pharm Biopharm 65:131-148.
15. Niesen FH, Berglund H, Vedadi M. 2007. The use of differential scanning fluorimetry to detect ligand interactions that promote protein stability. Nat Protoc 2:2212-2221.
16. Ausar SF, Espina M, Brock J, Thyagarayapuran N, Repetto R, Khandke L, Middaugh CR. 2007. High-throughput screening of stabilizers for respiratory syncytial virus: Identification of stabilizers and their effects on the conformational thermostability of viral particles. Hum Vaccine 3:94-103.
17. Ausar SF, Foubert TR, Hudson MH, Vedvick TS, Middaugh CR. 2006. Conformational stability and disassembly of Norwalk virus-like particles. Effect of pH and temperature. J Biol Chem 281:19478-19488.
18. Kissmann J, Ausar SF, Rudolph A, Braun C, Cape SP, Sievers RE, Federspiel MJ, Joshi SB, Middaugh CR. 2008. Stabilization of measles virus for vaccine formulation. Hum Vaccine 4:350-359.
19. Peek LJ, Brandau DT, Jones LS, Joshi SB, Middaugh CR. 2006. A systematic approach to stabilizing EBA-175 RII-NG for use as a malaria vaccine. Vaccine 24:5839-5851.
20. Senisterra GA, Finerty PJ Jr. 2009. High throughput methods of assessing protein stability and aggregation. Mol Biosyst 5:217-223.
21. Bai S, Dong A. 2009. Effects of immobilization onto aluminum hydroxide particles on the thermally induced conformational behavior of three model proteins. Int J Biol Macromol 45:80-85.
22. Dong A, Jones LS, Kerwin BA, Krishnan S, Carpenter JF. 2006. Secondary structures of proteins adsorbed onto aluminum hydroxide: Infrared spectroscopic analysis of proteins from low solution concentrations. Anal Biochem 351:282-289.
23. Jones LS, Peek LJ, Power J, Markham A, Yazzie B, Middaugh CR. 2005. Effects of adsorption to aluminum salt adjuvants on the structure and stability of model protein antigens. J Biol Chem 280:13406-13414.
24. Lo MC, Aulabaugh A, Jin G, Cowling R, Bard J, Malamas M, Ellestad G. 2004. Evaluation of fluorescence-based thermal shift assays for hit identification in drug discovery. Anal Biochem 332:153-159.
25. Hawe A, Sutter M, Jiskoot W. 2008. Extrinsic fluorescent dyes as tools for protein characterization. Pharm Res 25:1487-1499.
26. Romero MI, Shi Y, HogenEsch H, Hem SL. 2007. Potentiation of the immune response to non-adsorbed antigens by aluminum-containing adjuvants. Vaccine 25:825-833.
27. Volkin DB, Sanyal G, Burke CJ, Middaugh CR. 2002. Preformulation studies as an essential guide to formulation development and manufacture of protein pharmaceuticals. Pharm Biotechnol 14:1-46.
28. Wittayanukulluk A, Jiang D, Regnier FE, Hem SL. 2004. Effect of microenvironment pH of aluminum hydroxide adjuvant on the chemical stability of adsorbed antigen. Vaccine 22:1172-1176.
29. Capelle MA, Gurny R, Arvinte T. 2007. High throughput screening of protein formulation stability: Practical considerations. Eur J Pharm Biopharm 65:131-148.
30. Vedadi M, Niesen FH, lali-Hassani A, Fedorov OY, Finerty PJ Jr., Wasney GA, Yeung R, Arrowsmith C, Ball LJ, Berglund H, Hui R, Marsden BD, Nordlund P, Sundstrom M, Weigelt J, Edwards AM. 2006. Chemical screening methods to identify ligands that promote protein stability, protein crystallization, and structure determination. Proc Natl Acad Sci U S A 103:15835-15840.
31. Matulis D, Kranz JK, Salemme FR, Todd MJ. 2005. Thermodynamic stability of carbonic anhydrase: Measurements of binding affinity and stoichiometry using ThermoFluor. Biochemistry 44:5258-5266.
32. He F, Hogan S, Latypov RF, Narhi LO, Razinkov VI. 2010. High throughput thermostability screening of monoclonal antibody formulations. J Pharm Sci 99:1707-1720.
33. Peek LJ, Martin TT, Elk NC, Pegram SA, Middaugh CR. 2007. Effects of stabilizers on the destabilization of proteins upon adsorption to aluminum salt adjuvants. J Pharm Sci 96:547-557.
34. Lee JC, Timasheff SN. 1981. The stabilization of proteins by sucrose. J Biol Chem 256:7193-7201.
35. Kendrick BS, Chang BS, Arakawa T, Peterson B, Randolph TW, Manning MC, Carpenter JF. 1997. Preferential exclusion of sucrose from recombinant interleukin-1 receptor antagonist: Role in restricted conformational mobility and compaction of native state. Proc Natl Acad Sci U S A 94:11917-11922.
36. Lorizate M, Brugger B, Akiyama H, Glass B, Muller B, Anderluh G, Wieland FT, Krausslich HG. 2009. Probing HIV-1 membrane liquid order by Laurdan staining reveals producer cell-dependent differences. J Biol Chem 284:22238-22247.
37. Rexroad J, Wiethoff CM, Green AP, Kierstead TD, Scott MO, Middaugh CR. 2003. Structural stability of adenovirus type 5. J Pharm Sci 92:665-678.