Detection of IgG aggregation by a high throughput method based on extrinsic fluorescence

Journal of Pharmaceutical Sciences

Volumn 99, Issue 6, 2010, Pages 2598-2608

  He, Feng ^a   Phan, Duke H ^a   Hogan, Sabine ^a   Bailey, Robert ^a   Becker, Gerald W ^a   Narhi, Linda O ^b   Razinkov, Vladimir I ^a  

^a AMGEN INC   (United States)

^b AMGEN INC   (United States)

Author keywords

Fluorescence; High throughput; Monoclonal antibody; Protein aggregation; Size exclusion chromotography

Indexed keywords

IMMUNOGLOBULIN G;

ARTICLE; CONTROLLED STUDY; FLUORESCENCE; GEL PERMEATION CHROMATOGRAPHY; HIGH THROUGHPUT SCREENING; PROTEIN ANALYSIS; SENSITIVITY AND SPECIFICITY;

EID: 77951589043     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22036     Document Type: Article

References (36)

1. Mahler HC, Friess W, Grauschopf U, Kiese S. 2009. Protein aggregation: Pathways, induction factors and analysis. J Pharm Sci 98:2909-2934.
2. Fink AL. 1998. Protein aggregation: Folding aggregates, inclusion bodies and amyloid. Fold Des 3:R9-R23.
3. Fradkin AH, Carpenter JF, Randolph TW. 2009. Immunogenicity of aggregates of recombinant human growth hormone in mouse models. J Pharm Sci 98:3247-3264.
4. Rosenberg AS. 2006. Effects of protein aggregates: An immunologic perspective. AAPS J 8:E501-E507.
5. Ramsey JD, Gill ML, Kamerzell TJ, Price ES, Joshi SB, Bishop SM, Oliver CN, Middaugh CR. 2009. Using empirical phase diagrams to understand the role of intramolecular dynamics in immunoglobulin G stability. J Pharm Sci 98:2432-2447.
6. Zheng K, Middaugh CR, Siahaan TJ. 2009. Evaluation of the physical stability of the EC5 domain of E-cadherin: Effects of pH, temperature, ionic strength, and disulfide bonds. J Pharm Sci 98:63-73.
7. Kueltzo LA, Wang W, Randolph TW, Carpenter JF. 2008. Effects of solution conditions, processing parameters, and container materials on aggregation of a monoclonal antibody during freeze-thawing. J Pharm Sci 97:1801-1812.
8. Fesinmeyer RM, Hogan S, Saluja A, Brych SR, Kras E, Narhi LO, Brems DN, Gokarn YR. 2009. Effect of ions on agitation and temperature-induced aggregation reactions of antibodies. Pharm Res 26:903-913.
9. Philo JS. 2009. A critical review of methods for size characterization of non-particulate protein aggregates. Curr Pharm Biotechnol 10:359-372.
10. Hawe A, Friess W, Sutter M, Jiskoot W. 2008. Online fluorescent dye detection method for the characterization of immunoglobulin G aggregation by size exclusion chromatography and asymmetrical flow field flow fractionation. Anal Biochem 378:115-122.
11. Roda B, Zattoni A, Reschiglian P, Moon MH, Mirasoli M, Michelini E, Roda A. 2009. Field-flow fractionation in bioanalysis: A review of recent trends. Anal Chim Acta 635:132-143.
12. Andya JD, Hsu CC, Shire SJ. 2003. Mechanisms of aggregate formation and carbohydrate excipient stabilization of lyophilized humanized monoclonal antibody formulations. AAPS Pharm Sci 5:E10.
13. Kundu B, Shukla A, Guptasarma P. 2002. Manipulation of unfolding-induced protein aggregation by peptides selected for aggregate-binding ability through phage display library screening. Biochem Biophys Res Commun 291:903-907. (Pubitemid 34694360)
14. Philo JS, Arakawa T. 2009. Mechanisms of protein aggregation. Curr Pharm Biotechnol 10:348-351.
15. Gabellieri E, Strambini GB. 2006. ANS fluorescence detects widespread perturbations of protein tertiary structure in ice. Biophys J 90:3239-3245.
16. Hawe A, Sutter M, Jiskoot W. 2008. Extrinsic fluorescent dyes as tools for protein characterization. Pharm Res 25:1487-1499.
17. Koshiba T, Yao M, Kobashigawa Y, Demura M, Nakagawa A, Tanaka I, Kuwajima K, Nitta K. 2000. Structure and thermodynamics of the extraordinarily stable molten globule state of canine milk lysozyme. Biochemistry 39:3248-3257. (Pubitemid 30169993)
18. Muzammil S, Kumar Y, Tayyab S. 2000. Anion-induced refolding of human serum albumin under low pH conditions. Biochim Biophys Acta 1476:139-148. (Pubitemid 30001918)
19. Smoot AL, Panda M, Brazil BT, Buckle AM, Fersht AR, Horowitz PM. 2001. The binding of bis-ANS to the isolated GroEL apical domain fragment induces the formation of a folding intermediate with increased hydrophobic surface not observed in tetradecameric GroEL. Biochemistry 40:4484-4492. (Pubitemid 32319594)
20. Gasymov OK, Glasgow BJ. 2007. ANS fluorescence: Potential to augment the identification of the external binding sites of proteins. Biochim Biophys Acta 1774:403-411.
21. Fowler SD, Greenspan P. 1985. Application of Nile red, a fluorescent hydrophobic probe, for the detection of neutral lipid deposits in tissue sections: Comparison with oil red O. J Histochem Cytochem 33:833-836. (Pubitemid 15237754)
22. Greenspan P, Mayer EP, Fowler SD. 1985. Nile red: A selective fluorescent stain for intracellular lipid droplets. J Cell Biol 100:965-973. (Pubitemid 15135357)
23. Steensma DP. 2001. "Congo" red: Out of Africa? Arch Pathol Lab Med 125:250-252.
24. Harn N, Allan C, Oliver C, Middaugh CR. 2007. Highly concentrated monoclonal antibody solutions: Direct analysis of physical structure and thermal stability. J Pharm Sci 96: 532-546. (Pubitemid 46466076)
25. Treuheit MJ, Kosky AA, Brems DN. 2002. Inverse relationship of protein concentration and aggregation. Pharm Res 19:511-516.
26. Ericsson UB, Hallberg BM, Detitta GT, Dekker N, Nordlund P. 2006. Thermofluor-based high-throughput stability optimization of proteins for structural studies. Anal Biochem 357:289-298. (Pubitemid 44430091)
27. Lavinder JJ, Hari SB, Sullivan BJ, Magliery TJ. 2009. High-throughput thermal scanning: A general, rapid dye-binding thermal shift screen for protein engineering. J Am Chem Soc 131:3794-3795.
28. 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. (Pubitemid 351565860)
29. Pantoliano MW, Petrella EC, Kwasnoski JD, Lobanov VS, Myslik J, Graf E, Carver T, Asel E, Springer BA, Lane P, Salemme FR. 2001. High-density miniaturized thermal shift assays as a general strategy for drug discovery. J Biomol Screen 6:429-440. (Pubitemid 34052847)
30. Malawski GA, Hillig RC, Monteclaro F, Eberspaecher U, Schmitz AA, Crusius K, Huber M, Egner U, Donner P, Muller-Tiemann B. 2006. Identifying protein construct variants with increased crystallization propensity-A case study. Protein Sci 15:2718-2728. (Pubitemid 44833753)
31. He F, Hogan S, Latypov RF, Narhi LO, Razinkov VI. 2009. High throughput thermostability screening of monoclonal antibody formulations. J Pharm Sci September 24 (Epub ahead of print).
32. Hawe A, Kasper JC, Friess W, Jiskoot W. 2009. Structural properties of monoclonal antibody aggregates induced by freeze-thawing and thermal stress. Eur J Pharm Sci 38(2): 79-87.
33. Steinberg TH, Haugland RP, Singer VL. 1996. Applications of SYPRO orange and SYPRO red protein gel stains. Anal Biochem 239:238-245.
34. Steinberg TH, Jones LJ, Haugland RP, Singer VL. 1996. SYPRO orange and SYPRO red protein gel stains: One-step fluorescent staining of denaturing gels for detection of nanogram levels of protein. Anal Biochem 239:223-237.
35. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, Fan YX, Kirshner S, Verthelyi D, Kozlowski S, Clouse KA, Swann PG, Rosenberg A, Cherney B. 2009. Overlooking subvisible particles in therapeutic protein products: Gaps that may compromise product quality. J Pharm Sci 98:1201-1205.
36. Philo JS. 2006. Is any measurement method optimal for all aggregate sizes and types? AAPS J 8:E564-E571.