Low-Impurity Sucrose Lowers Risk of Protein Instability in Biopharmaceutical Formulation
A new sucrose product from MilliporeSigma has reduced nanoparticle impurities.
MilliporeSigma developed a new filtration-based manufacturing process resulting in a new, highly purified sucrose grade with reduced levels of nanoparticle impurities (NPI). The new product, Sucrose EMPROVE EXPERT Ph Eur, ChP, JP, NF, is useful for biopharmaceutical formulation as a protein-stabilizing excipient. The product is part of the company’s Emprove Program, which facilitates drug product manufacturers’ risk assessment workflows and supplier qualification.
MilliporeSigma designed the new purification process and associated nanoparticle analytics of sucrose in a collaboration with Coriolis Pharma. Compared to non-purified sucrose, the new product offers a low level of NPIs on the limit of detection of current technologies, reducing risk of protein stability; less interference with analytical methods; high batch-to-batch consistency; and a reduced risk of API damage.
Source: MilliporeSigma
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
