High-throughput assessment of antigen conformational stability by ultraviolet absorption spectroscopy and its application to excipient screening

Biotechnology and Bioengineering

Volumn 109, Issue 2, 2012, Pages 502-516

  Dasnoy, Sébastien ^a   Le Bras, Vivien ^b   Préat, Véronique ^a   Lemoine, Dominique ^b  

^a UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

^b GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

Author keywords

Excipients; High throughput screening; Protein; Ultraviolet absorption spectroscopy; Vaccine

Indexed keywords

ANALYTICAL METHOD; CONFORMATIONAL STABILITIES; EXCIPIENTS; FLUORIMETRY; GUANIDINE HYDROCHLORIDE; HIGH-THROUGHPUT; HIGH-THROUGHPUT SCREENING; MEDIAN POLISHS; NATIVE FORMS; PREDICTION MODEL; SODIUM DOCUSATE; TURBIDITY MEASUREMENTS; ULTRAVIOLET ABSORPTION SPECTROSCOPY; UNFOLDING METHOD;

AMINO ACIDS; FLUORESCENCE SPECTROSCOPY; MATHEMATICAL MODELS; PROTEINS; SODIUM; STABILITY; THROUGHPUT; TURBIDITY; VACCINES;

ANTIGENS;

2 HYDROXYPROPYL BETA CYCLODEXTRIN; ARGININE; BLOOD GROUP A ANTIGEN; BLOOD GROUP B ANTIGEN; CALCIUM CHLORIDE; DOCUSATE SODIUM; EXCIPIENT; GUANIDINE; INOSITOL; POLYOL; TREHALOSE; TRYPTOPHAN;

ABSORPTION SPECTROSCOPY; ARTICLE; CONTROLLED STUDY; DIFFERENTIAL SCANNING FLUORIMETRY; FLUORESCENCE SPECTROSCOPY; FLUOROMETRY; HIGH THROUGHPUT SCREENING; INTERMETHOD COMPARISON; OPTICAL DENSITY; PREDICTION; PROTEIN CONFORMATION; PROTEIN STABILITY; PROTEIN UNFOLDING; SENSITIVITY ANALYSIS; TITRIMETRY; ULTRAVIOLET ABSORPTION SPECTROSCOPY; ULTRAVIOLET SPECTROSCOPY;

ANTIGENS; CHEMISTRY, PHARMACEUTICAL; DRUG STABILITY; EXCIPIENTS; HIGH-THROUGHPUT SCREENING ASSAYS; MODELS, CHEMICAL; PROTEIN CONFORMATION; PROTEIN STABILITY; RECOMBINANT PROTEINS; REPRODUCIBILITY OF RESULTS; SPECTROPHOTOMETRY, ULTRAVIOLET; TRYPTOPHAN;

EID: 83555173592     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.23336     Document Type: Article

References (38)

1. Arakawa T, Timasheff SN. 1985. The stabilization of proteins by osmolytes. Biophys J 47: 411-414.
2. Arakawa T, Ejima D, Tsumoto K, Obeyama N, Tanaka Y, Kita Y, Timasheff SN. 2007. Suppression of protein interactions by arginine: A proposed mechanism of the arginine effects. Biophys Chem 127: 1-8.
3. Aucamp JP, Cosme AM, Lye GJ, Dalby PA. 2005. High-throughput measurement of protein stability in microtiter plates. Biotechnol Bioeng 89: 599-607.
4. 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 Vaccin 3: 94-103.
5. Capelle MA, Gurny R, Arvinte T. 2009. A high throughput protein formulation platform: Case study of salmon calcitonin. Pharm Res 26: 118-128.
6. Dasnoy S, Dezutter N, Lemoine D, Le Bras V, Préat V. 2011. High-throughput screening of excipients intended to prevent antigen aggregation at air-liquid interface. Pharm Res 28: 1591-1605.
7. Eftink MR. 2000. Use of fluorescence spectroscopy as thermodynamics tool. Methods Enzymol 323: 459-473.
8. He F, Joshi SB, Moore DS, Shinogle HE, Ohtake S, Lechuga-Ballesteros D, Martin RA, Truong-Le VL, Middaugh CR. 2010. Using spectroscopic and microscopic methods to probe the structural stability of human adenovirus type 4. Hum Vaccin 6: 202-211.
9. Hermeling S, Crommelin DJ, Schellekens H, Jiskoot W. 2004. Structure-immunogenicity relationships of therapeutic proteins. Pharm Res 21: 897-903.
10. Kissmann J, Ausar SF, Foubert TR, Brock J, Switzer MH, Detzi EJ, Vedvick TS, Middaugh CR. 2008a. Physical stabilization of Norwalk virus-like particles. J Pharm Sci 97: 4208-4218.
11. Kissmann J, Ausar SF, Rudolph A, Braun C, Cape SP, Sievers RE, Federspiel MJ, Joshi SB, Middaugh CR. 2008b. Stabilization of measles virus for vaccine formulation. Hum Vaccin 4: 350-359.
12. Kueltzo LA, Normand N, O'Hare P, Middaugh CR. 2000. Conformational lability of herpesvirus protein VP22. J Biol Chem 275: 33213-33221.
13. Lakowicz JR. 2004. Principles of fluorescence spectroscopy. New York: Springer. 725 p.
14. Leach SJ, Scheraga HA. 1960. Effect of light scattering on ultraviolet difference spectra. J Am Chem Soc 82: 4790-4792.
15. Liu PF, Avramova LV, Park C. 2009. Revisiting absorbance at 230nm as a protein unfolding probe. Anal Biochem 389: 165-170.
16. Mach H, Middaugh CR. 2011. Ultraviolet spectroscopy as a tool in therapeutic protein development. J Pharm Sci 100: 1214-1227.
17. Mahendrarajah K, Dalby PA, Wilkinson B, Jackson SE, Main ERG. 2011. A high-throughput fluorescence chemical denaturation assay as a general screen for protein-ligand binding. Anal Biochem 411: 155-157.
18. Malo N, Hanley JA, Carlile G, Liu J, Pelletier J, Thomas D, Nadon R. 2010. Experimental design and statistical methods for improved hit detection in high-throughput screening. J Biomol Screen 15: 990-1000.
19. McGown EL, Hafeman DG. 1998. Multichannel pipettor performance verified by measuring pathlength of reagent dispensed into a microplate. Anal Biochem 258: 155-157.
20. Pace CN, Scholtz JM. 1997. Measuring the conformational stability of a protein. In: Creighton TE, editor. Protein structure: A practical approach. New York: Oxford University Press. p 299-321.
21. Park MK, Park JH, Cho JH. 1989. Qualitative analysis by derivative spectrophotometry (II). Computer-assisted spectral analysis using derivative spectra and root mean of squares of differences. Arch Pharm Res 12: 289-294.
22. Peek LJ, Brey RN, Middaugh CR. 2007. A rapid, three-step process for the preformulation of a recombinant ricin toxin A-chain vaccine. J Pharm Sci 96: 44-60.
23. Prestrelski SJ, Arakawa T, Carpenter JF. 1993. Separation of freezing- and drying-induced denaturation of lyophilized proteins using stress-specific stabilization. II. Structural studies using infrared spectroscopy. Arch Biochem Biophys 303: 465-473.
24. Ragone R, Colonna G, Balestrieri C, Servillo L, Irace G. 1984. Determination of tyrosine exposure in proteins by second-derivative spectroscopy. Biochemistry 23: 1871-1875.
25. Savitzky A, Golay MJE. 1964. Smoothing and differentiation of data by simplified least squares procedures. Anal Chem 36: 1627-1639.
26. Sellers SP, Maa YF. 2005. Principles of biopharmaceutical protein formulation: an overview. Methods Mol Biol 308: 243-263.
27. Senisterra GA, Finerty PJ. 2009. High throughput methods of assessing protein stability and aggregation. Mol Biosyst 5: 217-223.
28. Senisterra GA, Soo HB, Park HW, Vedadi M. 2008. Application of high-throughput isothermal denaturation to assess protein stability and screen for ligands. J Biomol Screen 13: 337-342.
29. Shire SJ. 2009. Formulation and manufacturability of biologics. Curr Opin Biotechnol 20: 708-714.
30. Tavornvipas S, Hirayama F, Takeda S, Arima H, Uekama K. 2006. Effects of cyclodextrins on chemically and thermally induced unfolding and aggregation of lysozyme and basic fibroblast growth factor. J Pharm Sci 95: 2722-2729.
31. Thirumangalathu R, Krishnan S, Bondarenko P, Speed-Ricci M, Randolph TW, Carpenter JF, Brems DN. 2007. Oxidation of methionine residues in recombinant human interleukin-1 receptor antagonist: Implications of conformational stability on protein oxidation kinetics. Biochemistry 46: 6213-6224.
32. Thirumangalathu R, Krishnan S, Ricci MS, Brems DN, Randolph TW, Carpenter JF. 2009. Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution. J Pharm Sci 98: 3167-3181.
33. Thomson JA, Shirley BA, Grimsley GR, Pace CN. 1989. Conformational stability and mechanism of folding of ribonuclease T1. J Biol Chem 264: 11614-11620.
34. Tukey JW. 1977. Exploratory data analysis. Reading: Addison-Wesley. 688 p.
35. Vessely C, Estey T, Randolph TW, Henderson I, Cooper J, Nayar R, Braun LJ, Carpenter JF. 2009. Stability of a trivalent recombinant protein vaccine formulation against botulinum neurotoxin during storage in aqueous solution. J Pharm Sci 98: 2970-2993.
36. Wang W. 2005. Protein aggregation and its inhibition in biopharmaceutics. Int J Pharm 289: 1-30.
37. Zhang JH, Chung TD, Oldenburg KR. 1999. A simple statistical parameter for use in evaluation and validation of high throughput screening assays. J Biomol Screen 4: 67-73.
38. Zhao H, Graf O, Milovic N, Luan X, Bluemel M, Smolny M, Forrer K. 2010. Formulation development of antibodies using robotic system and High-Throughput Laboratory (HTL). J Pharm Sci 99: 2279-2294.