NDLI: Intermolecular Interactions and the Viscosity of Highly Concentrated Monoclonal Antibody Solutions

Content Provider	Springer Nature Link
Author	Binabaji, Elaheh Ma, Junfen Zydney, Andrew L
Copyright Year	2015
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 IgG$_{1}$ monoclonal antibody over a wide range of protein concentrations, solution pH, ionic strength, and in the presence / absence of different excipients.Experiments were performed with an IgG$_{1}$ monoclonal antibody provided by Amgen. The steady-state viscosity was evaluated using a Rheometrics strain-controlled rotational rheometer with a concentric cylinder geometry.The viscosity data were well-described 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 work.These results provide important insights into the effects of intermolecular protein-protein interactions on the behavior of highly concentrated antibody solutions.
Starting Page	3102
Ending Page	3109
Page Count	8
File Format	PDF
ISSN	07248741
Journal	Pharmaceutical Research
Volume Number	32
Issue Number	9
e-ISSN	1573904X
Language	English
Publisher	Springer US
Publisher Date	2015-04-02
Publisher Place	New York
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacology/Toxicology Pharmacy Biochemistry Medical Law Biomedical Engineering
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Pharmacology Molecular Medicine Pharmacology (medical) Biotechnology Pharmaceutical Science

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