Low-Impurity Sucrose Lowers Risk of Protein Instability in Biopharmaceutical Formulation

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