Authors: Elaheh Binabaji Junfen Ma Andrew L Zydney
Publish Date: 2015/04/02
Volume: 32, Issue: 9, Pages: 3102-3109
Abstract
The large increase in viscosity of highly concentrated monoclonal antibody solutions can be challenging for downstream processing drug formulation and delivery steps The objective of this work was to examine the viscosity of highly concentrated solutions of a high purity IgG1 monoclonal antibody over a wide range of protein concentrations solution pH ionic strength and in the presence / absence of different excipientsThe viscosity data were welldescribed by the Mooney equation The data were analyzed in terms of the antibody virial coefficients obtained from osmotic pressure data evaluated under the same conditions The viscosity coefficient in the absence of excipients was well correlated with the third osmotic virial coefficient which has a negative value corresponding to short range attractive interactions at the pH and ionic strength examined in this workThe authors would like to acknowledge Amgen Inc for donation of the monoclonal antibody and for their financial support The authors would also like to thank Dr Ralph Colby in the Department of Materials Science and Engineering at Penn State for use of the RFS II Rheometrics Fluids Spectrometer
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