Merck 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 the ideal choice for the high-risk applications of manufacturing and formulating biomolecules.
As a widely used protein stabilizer for biomolecule formulation, the quality of sucrose is crucial. In an exclusive collaboration with Coriolis Pharma, Merck designed the new purification process and associated nanoparticle analytics of sucrose. The result is a highly pure sucrose that offers the following benefits over non-purified sucrose:
- A low level of NPIs on the limit of detection of current technologies, reducing the risk for protein instability
- Less interference with analytical methods
- High batch-to-batch consistency
- Reduced risk of API damage
Sucrose EMPROVE® EXPERT Ph Eur, ChP, JP, NF is part of Merck’s broad portfolio of protein stabilizing excipients including trehalose, mannitol, sorbitol and glycine. The new offering is part of the company’s Emprove® Program, which facilitates drug product manufacturers’ risk assessment workflows and supplier qualification.
Experts from Merck will be available at booth 1037, November 3-5, at the American Association of Pharmaceutical Scientists’ PharmSci 360 conference in San Antonio, Texas, to discuss the new offering. Experts will also be available at booth 80N40, November 5-7, at CPhI Worldwide conference in Frankfurt, Germany.