Polysorbate 20 prevents the precipitation of a monoclonal antibody during shear Viscosity of monoclonal antibodies under shear

Pharmaceutical Development and Technology

Volumn 14, Issue 6, 2009, Pages 659-664

  Patapoff, Thomas W ^a   Esue, Osigwe ^a  

^a GENENTECH INC   (United States)

Author keywords

Bulk viscosity; Interfacial viscosity; Mechanical; Monoclonal antibody; Protein precipitation; Shear thinning

Indexed keywords

MONOCLONAL ANTIBODY; POLYSORBATE 20; WATER;

AIR; ARTICLE; CONTROLLED STUDY; HUMAN; HYDROPHOBICITY; HYPOTHESIS; LIQUID; MOLECULAR INTERACTION; PRECIPITATION; PRIORITY JOURNAL; SHEAR FLOW; SURFACE TENSION; VISCOMETER; VISCOSITY;

ANTIBODIES, MONOCLONAL; CHEMICAL PRECIPITATION; CHEMISTRY, PHARMACEUTICAL; EXCIPIENTS; HUMANS; MECHANICAL PHENOMENA; POLYSORBATES; PROTEIN DENATURATION; PROTEIN STABILITY; RHEOLOGY; SURFACE TENSION; SURFACE-ACTIVE AGENTS; TECHNOLOGY, PHARMACEUTICAL; VISCOSITY;

EID: 70449436442     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.3109/10837450902911929     Document Type: Article

References (39)

1. Maggon K. Monoclonal antibody 'gold rush'. Curr Med Chem. 2007;14(18):1978-1987.
2. Lao-araya M, et al. Antibody response to hepatitis B re-vaccination in HIV-infected children with immune recovery on highly active antiretroviral therapy. Vaccine. 2007;25(29):5324-5329.
3. Nabi HA, Doerr RJ. Radiolabeled monoclonal antibody imaging (immunoscintigraphy) of colorectal cancers: Current status and future perspectives. Am J Surg. 1992;163(4):448-456.
4. Wang J, et al. Novel template-assembled oligosaccharide clusters as epitope mimics for HIV-neutralizing antibody 2G12. Design, synthesis, and antibody binding study. Org Biomol Chem. 2007;5(10):1529-1540.
5. Sane SU, et al. Raman spectroscopic characterization of drying- induced structural changes in a therapeutic antibody: Correlating structural changes with long-term stability. J Pharm Sci. 2004;93(4):1005-1018.
6. Harris M. Monoclonal antibodies as therapeutic agents for cancer. Lancet Oncol. 2004;5(5):292-302.
7. Kanai S, Liu J, Patapoff TW, Shire SJ 2008. Reversible self- association of a concentrated monoclonal antibody solution mediated by Fab-Fab interaction that impacts solution viscosity. J Pharm Sci. 10(42):4219-4227.
8. Kovar, M. et al. Star structure of antibody-targeted HPMA copolymer- bound doxorubicin: A novel type of polymeric conjugate for targeted drug delivery with potent antitumor effect. Bioconjug Chem. 2002;13(2):206-215.
9. Lu ZR, et al. Preparation and biological evaluation of polymerizable antibody Fab' fragment targeted polymeric drug delivery system. J Control Release. 2001;74(1-3):263-268.
10. Huang J, et al. Intranasal administration of dry powder anthrax vaccine provides protection against lethal aerosol spore challenge. Hum Vaccin. 2007;3(3):90-93.
11. Gupta B, et al. Monoclonal antibody 2C5-mediated binding of liposomes to brain tumor cells in vitro and in subcutaneous tumor model in vivo. J Drug Target. 2005;13(6):337-343.
12. Perrie Y, et al. Surfactant vesicle-mediated delivery of DNA vaccines via the subcutaneous route. Int J Pharm. 2004;284(1- 2):31-41.
13. Uchida T, et al. Particle size studies for subcutaneous delivery of poly(lactide-co-glycolide) microspheres containing ovalbumin as vaccine formulation. J Pharm Pharmacol. 1995;47(7):556-560.
14. Gardulf A, et al. Rapid subcutaneous IgG replacement therapy at home for pregnant immunodeficient women. J Clin Immunol. 2001;21(2):150-154.
15. Zhang F, et al. Protein interactions studied by SAXS: Effect of ionic strength and protein concentration for BSA in aqueous solutions. J Phys Chem B. 2007;111(1):251-259.
16. Liu Y, et al. Effective long-range attraction between protein molecules in solutions studied by small angle neutron scattering. Phys Rev Lett. 2005;95(11):118102.
17. Moore JM, et al. Kinetics and thermodynamics of dimer formation and dissociation for a recombinant humanized monoclonal antibody to vascular endothelial growth factor. Biochemistry. 1999;38(42):13960-13967.
18. Cromwell ME, et al. Protein aggregation and bioprocessing. AAPS J. 2006;8(3):E572-579.
19. Minton AP. Macromolecular crowding. Curr Biol. 2006;16(8):R269-271.
20. Perham M, et al. Macromolecular crowding increases structural content of folded proteins. FEBS Lett. 2007;581(26):5065-5069.
21. Levine HL, et al. The use of surface tension measurements in the design of antibody-based product formulations. J Parenter Sci Technol. 1991;45(3):160-165.
22. Vidanovic D, et al. Effects of nonionic surfactants on the physical stability of immunoglobulin G in aqueous solution during mechanical agitation. Pharmazie. 2003;58(6):399-404.
23. Biddlecombe JG, et al. Determining antibody stability: Creation of solid-liquid interfacial effects within a high shear environment. Biotechnol Prog. 2007;23(5):1218-1222.
24. Beverung CJ, et al. Protein adsorption at the oil/water interface: Characterization of adsorption kinetics by dynamic interfacial tension measurements. Biophys Chem. 1999;81(1):59-80.
25. Roberts SA, et al. Combined surface pressure-interfacial shear rheology studies of the interaction of proteins with spread phospholipid monolayers at the air-water interface. Int J Pharm. 2005;300(1-2):48-55.
26. Weinberg RB, et al. Interfacial properties of recombinant human cholesterol ester transfer protein. J Biol Chem. 1994;269(47):29588-29591.
27. Wang Z, Narsimhan G. Interfacial dilatational elasticity and viscosity of beta-lactoglobulin at air-water interface using pulsating bubble tensiometry. Langmuir. 2005;21(10):4482-4489.
28. Krishnan A, et al. Scaled interfacial activity of proteins at a hydrophobic solid/aqueous-buffer interface. J Biomed Mater Res A. 2005;75(2):445-457.
29. Kim DA, et al. Effect of thermal treatment on interfacial properties of beta-lactoglobulin. J Colloid Interface Sci. 2005;285(1):100-109.
30. Charm SE, Wong BL. Shear degradation of fibrinogen in the circulation. Science. 1970;170:(956):466-468.
31. Kiese S, Pappenberger A, Friess W, Mahler HC 2008. Shaken, not stirred: Mechanical stress testing of an IgG1 antibody. J Pharm Sci. 97:(10):4347-4366.
32. Liu J, et al. Reversible self-association increases the viscosity of a concentrated monoclonal antibody in aqueous solution. J Pharm Sci. 2005;94(9):1928-1940.
33. Prazeres TJ, et al. Correlations between the viscoelastic behavior of pyrene-labeled associative polymers and the associations of their fluorescent hydrophobes. J Phys Chem B. 2005;109(37):17406-17416.
34. Hardingham TE, et al. Viscoelastic properties of proteoglycan solutions with varying proportions present as aggregates. J Orthop Res. 1987;5(1):36-46.
35. Yamada S, et al. The mechanical properties of simple epithelial keratins 8 and 18: Discriminating between interfacial and bulk elasticities. J Struct Biol. 2003;143(1):45-55.
36. Szilvay GR, et al. Self-assembled hydrophobin protein films at the air-water interface: Structural analysis and molecular engineering. Biochemistry. 2007;46(9):2345-2354.
37. Gicquaud C, et al. Adsorption of actin at the air-water interface: A monolayer study. Biopolymers. 2003;70(3):289-296.
38. Shelton KR 1976. Selective effects of nonionic detergent and salt solutions in dissolving nuclear envelope protein. 20U. Biochim Biophys Acta. 455(3):973-982.
39. Oliva A, et al. Effect of high shear rate on stability of proteins: Kinetic study. J Pharm Biomed Anal. 2003;33(2):145-155.