Nanoparticulate Impurities Isolated from Pharmaceutical-Grade Sucrose Are a Potential Threat to Protein Stability
Sign Up to like & getrecommendations! Published in 2017 at "Pharmaceutical Research"
DOI: 10.1007/s11095-017-2274-4
Abstract: PurposeTo investigate the effect of nanoparticulate impurities (NPIs) isolated from pharmaceutical-grade sucrose, on the stability of monoclonal antibodies (mAbs).MethodsNPIs were purified from pharmaceutical-grade sucrose and spiked into trastuzumab, rituximab, infliximab, and cetuximab formulations. The stability… read more here.
Keywords: isolated pharmaceutical; grade sucrose; nanoparticulate impurities; pharmaceutical grade ... See more keywords
Immunological evaluation in vitro of nanoparticulate impurities isolated from pharmaceutical-grade sucrose.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2020.11.011
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 100 - 200 nm in pharmaceutical-grade sucrose. Furthermore, isolated… read more here.
Keywords: nanoparticulate impurities; grade sucrose; vitro; pharmaceutical grade ... See more keywords