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Int J Pharm ; 626: 122204, 2022 Oct 15.
Article in English | MEDLINE | ID: mdl-36116691

ABSTRACT

Addition of pharmaceutical excipients is a commonly used approach to decrease the viscosity of highly concentrated protein formulations, which otherwise could not be subcutaneously injected or processed. The variety of protein-protein interactions, which are responsible for increased viscosities, makes a portfolio approach necessary. Screening of several excipients to develop such a portfolio is time and money consuming in industrial settings. Responsible protein-protein interactions were investigated using the interaction parameter kD obtained from dynamic light scattering measurements in the studies presented herein. Together with in-silico calculated excipient parameter, kD could be used as a screening tool accelerating screening and formulation development as kD is suitable to high-throughput formats using small quantities of protein and low concentrations. A qualitative correlation between kD and high-concentration viscosity behavior could be shown in our case.


Subject(s)
Excipients , Immunoglobulin G , Antibodies, Monoclonal , Industrial Development , Viscosity
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