volume 110, issue 2, P952-958 2021
DOI: 10.1016/j.xphs.2020.11.011
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Abstract: Sucrose is a commonly used stabilizing excipient in protein formulations. However, recent studies have indicated the presence of nanoparticulate impurities (NPIs) in the size range of 100e200 nm in pharmaceutical-grade sucrose. Furthermore, isolated NPIs have been shown to induce protein aggregation when added to monoclonal antibody formulations. Moreover, nanoparticles are popular vaccine delivery systems used to increase the immunogenicity of antigens. Therefore, we hypothesized that NPIs may have immunostim…

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