Viscosity of concentrated therapeutic protein compositions.
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 toward 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.
Arecor Limited, 2 Cambridge Science Park, Cambridge, CB4 0FE, UK. jan.jezek@arecor.com
Jan
J
Jezek
Martin
M
Rides
Barry
B
Derham
Jonathan
J
Moore
Elenora
E
Cerasoli
Robert
R
Simler
Bernardo
B
Perez-Ramirez
D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000737:chemistry*; D016503:Drug Delivery Systems; D015195:Drug Design; D004355:Drug Stability; D006801:Humans; D011506:Proteins / Q000008:administration & dosage / Q000737:chemistry*; D012212:Rheology; D014783:Viscosity
D000911:Antibodies, Monoclonal; D011506:Proteins