Monitoring protein aggregation kinetics with simultaneous multiple sample light scattering

Analytical Biochemistry

Volumn 437, Issue 2, 2013, Pages 185-197

  Drenski, Michael F ^a   Brader, Mark L ^b   Alston, Roy W ^b   Reed, Wayne F ^a  

^a Tulane University   (United States)

^b BIOGEN   (United States)

Author keywords

Aggregation kinetics; High concentration monoclonal antibody; High concentration protein formulation; High throughput screening; Light scattering; Protein aggregation

Indexed keywords

ACTIVATION ENERGY; KINETICS; MONOCLONAL ANTIBODIES; STOCHASTIC SYSTEMS;

AGGREGATION BEHAVIOR; AGGREGATION KINETICS; CONTINUOUS MONITORING; HIGH THROUGHPUT SCREENING; HYDRODYNAMIC DIAMETER; MONOCLONAL ANTIBODIES (MAB); PROTEIN AGGREGATION; PROTEIN FORMULATION;

LIGHT SCATTERING;

MONOCLONAL ANTIBODY;

ARTICLE; CONCENTRATION (PARAMETERS); CROSSING OVER; ENERGY YIELD; HYDRODYNAMICS; INTERFEROMETER; KINETICS; LIGHT SCATTERING; PRIORITY JOURNAL; PROTEIN AGGREGATION; PROTEIN ANALYSIS; PROTEIN DOMAIN; PROTEIN FOLDING; PROTEIN STRUCTURE; SIMULTANEOUS MULTIPLE SAMPLE LIGHT SCATTERING; STOCHASTIC MODEL; TEMPERATURE;

EID: 84876912537     PISSN: 00032697     EISSN: 10960309     Source Type: Journal    
DOI: 10.1016/j.ab.2013.02.014     Document Type: Article

References (39)

1. M.E.M. Cromwell, E. Hilario, and F. Jacobson Protein aggregation and bioprocessing AAPS J. 8 2006 E572 E579
2. H.C. Mahler, W. Friess, U. Grauschopf, and S. Kiese Protein aggregation: pathways, induction factors, and analysis J. Pharm. Sci. 98 2009 2909 2934
3. E.Y. Chi, S. Krishnan, T.W. Randolph, and J.F. Carpenter Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation Pharm. Res. 20 2003 1325 1336 (Pubitemid 37164039)
4. C.J. Roberts Kinetics of irreversible protein aggregation: analysis of extended Lumry-Eyring models and implications for predicting protein shelf life J. Phys. Chem. B 107 2003 1194 1207
5. J.F. Carpenter, T.W. Randolph, W. Jiskoot, D.J.A. Crommelin, C.R. Middaugh, G. Winter, Y.X. Fan, S. Kirshner, D. Verthelyi, S. Kozlowski, K.A. Clouse, P.G. Swann, A. Rosenberg, and B. Cherney Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality J. Pharm. Sci. 98 2009 1201 1205
6. A.S. Rosenberg Effects of protein aggregates: an immunologic perspective AAPS J. 8 2006 E501 E507
7. H. Schellekens The immunogenicity of therapeutic proteins Discov. Med. 9 2010 560 564
8. A. Saluja, and D.S. Kalonia Nature and consequences of protein-protein interactions in high protein concentration solutions Int. J. Pharm. 358 2008 1 15
9. J.P. Gabrielson, M.L. Brader, A.H. Pekar, K.B. Mathis, G. Winter, J.F. Carpenter, and T.W. Randolph Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity J. Pharm. Sci. 96 2007 268 279 (Pubitemid 46363558)
10. J.S. Philo A critical review of methods for size characterization of non-particulate protein aggregates Curr. Pharm. Biotechnol. 10 2009 359 372
11. Y. Li, W.F. Weiss, and C.J. Roberts Characterization of high-molecular-weight nonnative aggregates and aggregation kinetics by size exclusion chromatography with inline multi-angle laser light scattering J. Pharm. Sci. 98 2009 3997 4016
12. A. Malloy Count, size, and visualize nanoparticles Mater. Today 14 2011 170 173
13. V. Filipe, A. Hawe, and W. Jiskoot Critical evaluation of nanoparticle tracking analysis (NTA) by NanoSight for the measurement of nanoparticles and protein aggregates Pharm. Res. 27 2010 796 810
14. J.G. Barnard, S. Singh, T.W. Randolph, and J.F. Carpenter Subvisible particle counting provides a sensitive method of detecting and quantifying aggregation of monoclonal antibody caused by freeze-thawing: insights into the roles of particles in the protein aggregation pathway J. Pharm. Sci. 100 2011 492 503
15. C.T. Huang, D. Sharma, P. Oma, and R. Krishnamurthy Quantitation of protein particles in parenteral solutions using micro-flow imaging J. Pharm. Sci. 98 2009 3058 3071
16. W.F. Reed, Device and method of simultaneously measuring the light scattering from multiple liquid samples containing polymers and/or colloids, U.S. patent 6,618,144.
17. M.F. Drenski, and W.F. Reed Simultaneous multiple sample light scattering for analysis of polymer solutions J. Appl. Polym. Sci. 92 2004 2724 2732 (Pubitemid 38476151)
18. M.F. Drenski, E. Mignard, A.M. Alb, and W.F. Reed Simultaneous in-situ monitoring of parallel polymerization reactions using light scattering; A new tool for high-throughput screening J. Comb. Chem. 6 2004 710 716 (Pubitemid 39329425)
19. B.J. Berne, and R. Pecora Dynamic Light Scattering 1990 Krieger Malabar, FL
20. E.M. Lyutova, A.S. Kasakov, and B.Y. Gurvits Effects of arginine on kinetics of protein aggregation studied by dynamic laser light scattering and tubidimetry techniques Biotechnol. Prog. 23 2007 1411 1416 (Pubitemid 350261877)
21. H. Wu, J.J. Xie, and M. Morbidelli Kinetics of cold-set diffusion-limited aggregations of denatured whey protein isolate colloids Biomacromolecules 6 2005 3189 3197 (Pubitemid 41764078)
22. Y. Panyukov, I. Yudin, V. Drachev, E. Dobrov, and B. Kurganov The study of amorphous aggregation of tobacco mosaic virus coat protein by dynamic light scattering Biophys. Chem. 127 2007 9 18
23. F. Sokolowski, A.J. Modler, R. Masuch, D. Zirwer, M. Baier, G. Lutsch, D.A. Moss, K. Gast, and D. Naumann Formation of critical oligomers is a key event during conformational transition of recombinant Syrian hamster prion protein J. Biol. Chem. 278 2003 40481 40492 (Pubitemid 37280858)
24. H.Y. Zhao, P.H. Brown, and P. Schuckt On the distribution of protein refractive index increments Biophys. J. 100 2011 2309 2317
25. D.J. Slotboom, R.H. Duurkens, K. Olieman, and G.B. Erkens Static light scattering to characterize membrane proteins in detergent solution Methods 46 2008 73 82
26. C. Fernandez, and A.P. Minton Automated measurement of the static light scattering of macromolecular solutions over a broad range of concentrations Anal. Biochem. 381 2008 254 257
27. H. Bajaj, V.K. Sharma, A. Badkar, D. Zeng, S. Nema, and D.S. Kalonia Protein structural conformation and not second virial coefficient relates to long-term irreversible aggregation of a monoclonal antibody and ovalbumin in solution Pharm. Res. 23 2006 1382 1394 (Pubitemid 43946160)
28. J.P. Hansen, and I.R. McDonald Theory of Simple Liquids 1986 Academic Press San Diego
29. D.C. Rau, and V.A. Parsegian Direct measurement of the intermolecular forces between counterion-condensed DNA double helices: evidence for long range attractive hydration forces Biophys. J. 61 1992 246 259
30. G.A. Sorci, and W.F. Reed Electrostatically enhanced second and third virial coefficients, viscosity, and interparticle correlations for linear polyelectrolytes Macromolecules 35 2002 5218 5227 (Pubitemid 34691652)
31. D. Wu, and A.P. Minton Quantitative characterization of the interaction between sucrose and native proteins via static light scattering J. Phys. Chem. B 117 2013 111 117
32. E. Garber, and S.J. Demarest A broad range of Fab stabilities within a host of therapeutic IgGs Biochem. Biophys. Res. Commun. 355 2007 751 757 (Pubitemid 46343718)
33. A.E. Mirsky, and L. Pauling On the structure of native, denatured, and coagulated proteins Proc. Natl. Acad. Sci. U.S.A. 22 1936 439 447
34. J.S. Bee, J.L. Stevenson, B. Mehta, J. Svitel, J. Pollastrini, R. Platz, E. Freund, J.F. Carpenter, and T.W. Randolph Response of a concentrated monoclonal antibody formulation to high shear Biotechnol. Bioeng. 103 2009 936 943
35. J. Rubin, A. San Miguel, A.S. Bommarius, and S.H. Behrens Correlating aggregation kinetics and stationary diffusion in protein-sodium salt systems observed with dynamic light scattering J. Phys. Chem. B 114 2013 4383 4387
36. C.M. Dobson Principles of protein folding, misfolding, and aggregation Semin. Cell Dev. Biol. 15 2004 3 16 (Pubitemid 38177363)
37. C.J. Roberts Non-native protein aggregation kinetics Biotechnol. Bioeng. 98 2007 927 938 (Pubitemid 350205571)
38. Y. Li, and C.J. Roberts Lumry-Eyring nucleated polymerization model of protein aggregation kinetics: 2. Competing growth via condensation and chain polymerization J. Phys. Chem. B 113 2009 7020 7032
39. K. Martin, M. Dotson, M. Litterer, T.W. Hanks, and C. Veas Polymerization of dicarbonyl(5-cyclopentadienyl) (1-pyrrolyl) iron(II): a new class of conducting polymers Synth. Met. 78 1996 161 168 (Pubitemid 126392180)