journal article Open Access Sep 01, 2006

Protein aggregation and bioprocessing

View at Publisher Save 10.1208/aapsj080366
Topics

No keywords indexed for this article. Browse by subject →

References
23
[1]
US Pharmacopeia. USP/NF General Chapter<788> Particulate Matter in Injections. In: U.S. Pharmacopeia, ed.National Formulary, USP29-NF-24 (suppl 2). Rockville, MD: USP; 2006.
[2]
Andya JD, Hsu CC, Shire SJ. Mechanisms of aggregate formation and carbohydrate excipient stabilization of lyophilized humanized monoclonal antibody formulations.AAPS PharmSci. 2003;5:E10. 10.1208/ps050210
[3]
Shahrokh Z, Sluzky V, Stratton PR, Eberlein GA, Wang YJ. Disulfide-linked oligomerization of basic fibroblast growth factors: effect of sulfated compounds. In:Formulation and Delivery of Proteins and Peptides, ACS Symposium Series 567. Washington, DC: American Chemical Society, 1994:85–99. 10.1021/bk-1994-0567.ch006
[4]
Creed D. The photophysics and photochemistry of the near-UV absorbing amino acids. II. Tyrosine and its simple derivatives.Photochem Photobiol. 1984;39:563–575. 10.1111/j.1751-1097.1984.tb03891.x
[5]
Giulivi C, Davies KJA. Dityrosine: a marker for oxidatively modified proteins and selective proteolysis. In: Packer L, ed.Methods in Enzymology. vol. 233. New York, NY: Academic Press; 1994:363–371.
[6]
Moore JM, Patapoff TW, Cromwell MEM. Kinetics and thermodynamics of dimer formation and dissociation for a recombinant humanized monoclonal antibody to vascular endothelial growth factor.Biochemistry. 1999;38:13960–13967. 10.1021/bi9905516
[7]
Liu J, Nguyen MD, Andya JD, Shire SJ. Reversible self-association increases the viscosity of a concentrated monoclonal antibody in aqueous solution.J Pharm Sci. 2005;94:1928–1940. 10.1002/jps.20347
[8]
Maislos M, Bialer M, Mead PM, Robbins DC. Pharmacokinetic model of circulating covalent aggregates of insulin.Diabetes. 1988;37:1059–1063. 10.2337/diab.37.8.1059
[9]
Effects of protein aggregates: An immunologic perspective

Amy S. Rosenberg

The AAPS Journal 2006 10.1208/aapsj080359
[10]
Fernández A. What factor drives the fibrillogenic association of β-sheets?FEBS Lett. 2005;579:6635–6640. 10.1016/j.febslet.2005.10.058
[11]
Physical Stability of Proteins in Aqueous Solution: Mechanism and Driving Forces in Nonnative Protein Aggregation

Eva Y. Chi, Sampathkumar Krishnan, Theodore W. Randolph et al.

Pharmaceutical Research 2003 10.1023/a:1025771421906
[12]
Zhang YB, Howitt J, McCorkle S, Lawrence P, Springer K, Freimuth P. Protein aggregation during overexpression limited by peptide extensions with large net negative change.Protein Expr Purif. 2004;36:207–216. 10.1016/j.pep.2004.04.020
[13]
Freimuth P, Springer K, Berard C, Hainfeld J, Bewley M, Flanagan J. Coxsackievirus and adenovirus receptor amino-terminal immunoglobulin V-related domain binds adenovirus type 2 and fiber knob from adenovirus type 12.J Virol. 1999;73:1392–1398. 10.1128/jvi.73.2.1392-1398.1999
[14]
Frand AR, Cuozzo JW, Kaiser CA. Pathways for protein disulphide bond formation.Trends Cell Biol. 2000;10:203–210. 10.1016/s0962-8924(00)01745-1
[15]
Zhang W, Czupryn MJ. Free sulfhydryl in recombinant monoclonal antibodies.Biotechnol Prog. 2002;18:509–513. 10.1021/bp025511z
[16]
Chaderjian WB, Chin ET, Harris RJ, Etcheverry TM. Effect of copper sulfate on performance of a serum-free CHO cell culture process and the level of free thiol in the recombinant antibody expressed.Biotechnol Prog. 2005;21:550–553. 10.1021/bp0497029
[17]
Phillips J, Drumm A, Harrison P, et al. Manufacture and quality control of CAMPATH-1 antibodies for clinical trials.Cytotherapy. 2001;3:233–242. 10.1080/146532401753174061
[18]
Ejima D, Yumioka R, Tsumoto K, Arakawa T. Effective elution of antibodies by arginine and arginine derivatives in affinity column chromatography.Anal Biochem. 2005;345:250–257. 10.1016/j.ab.2005.07.004
[19]
Ansaldi D, Lester P, inventors. Genentech, Inc., assignee. Separation of polypeptide monomers. US patent 6 620 918. September 16, 2003.
[20]
van Reis R, Zydney A. Membrane separations in biotechnology.Curr Opin Biotechnol. 2001;12:208–211. 10.1016/s0958-1669(00)00201-9
[21]
Commercial manufacturing scale formulation and analytical characterization of therapeutic recombinant antibodies

Reed J. Harris, Steven J. Shire, Charles Winter

Drug Development Research 2004 10.1002/ddr.10344
[22]
van Reis R, Goodrich EM, Yson CL, Frautschy LN, Dzengeleski S, Lutz H. Linear scale ultrafiltration.Biotechnol Bioeng. 1997;55:737–746. 10.1002/(sici)1097-0290(19970905)55:5<737::aid-bit4>3.0.co;2-c
[23]
Wan Y, Vasan S, Ghosh R, Hale G, Cui Z. Separation of monoclonal antibody alemtuzumab monomer and dimers using ultrafiltration.Biotechnol Bioeng. 2005;90:422–432. 10.1002/bit.20416
Cited By
658
International Journal of Pharmaceut...
European Journal of Pharmaceutical...
A review on parenteral delivery of peptides and proteins

Divisha Jain, S. Shahe Mahammad · 2019

Drug Development and Industrial Pha...
International Journal of Biological...
Annual Review of Cell and Developme...
Journal of Pharmaceutical Sciences
Protein Stability During Bioprocessing

Mark Cornell Manning, Gabriel J. Evans · 2010

Formulation and Process Development...
Journal of Pharmaceutical Sciences
Journal of Pharmaceutical Sciences
Journal of Pharmaceutical Sciences
Biotechnology and Bioengineering
Metrics
658
Citations
23
References
Details
Published
Sep 01, 2006
Vol/Issue
8(3)
Pages
E572-E579
License
View
Cite This Article
Mary E. M. Cromwell, Eric Hilario, Fred Jacobson (2006). Protein aggregation and bioprocessing. The AAPS Journal, 8(3), E572-E579. https://doi.org/10.1208/aapsj080366
Related

You May Also Like