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Viscosity of concentrated therapeutic protein compositions.

Jazek, J*; Rides, M; Derham, B*; Moore, J; Cerasoli, E; Simler, R*; Perez-Ramirez, B* (2011) Viscosity of concentrated therapeutic protein compositions. Adv. Drug Delivery Rev., 63 (13). pp. 1107-1117.

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The use of monoclonal antibodies as therapeutic agents has been increasing steadily over the last decade for the treatment of various conditions. There is often a need to deliver a large dose of the protein, so there is a trend towards developing commercially viable liquid formulations of highly concentrated antibodies. Such concentrated solutions are associated with a number of challenges, including optimization of production processes, plus chemical and physical stability of the final product where solution viscosity becomes a critical quality attribute. Assessment of the rheological characteristics of concentrated compositions is essential as are development strategies to reduce the viscosity. This review covers the state-of-the art rheology measurement techniques, focusing particularly on concentrated protein solutions. Current understanding of the mechanisms leading to high viscosity and control by formulation parameters is discussed. Finally, original viscosity measurements with a shear sensitive immunoglobulin are shown, focusing on small sample volumes.

Item Type: Article
Keywords: Rheology, formulation, antibody, shear, surfactant
Subjects: Advanced Materials
Advanced Materials > Rheology and Viscosity
Identification number/DOI: 10.1016/j.addr.2011.09.008
Last Modified: 02 Feb 2018 13:14
URI: http://eprintspublications.npl.co.uk/id/eprint/5292

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