This story originally ran on May 6.
Waters and Ireland's National Institute for Bioprocessing Research and Training today announced that they are building the world's first database for glycan analysis by Ultra Performance Liquid Chromatography.
The database will be developed by Pauline Rudd's group at NIBRT and will serve as a repository of chromatographic retention times for sets of glycan structures that are associated with a range of biotherapeutics, the two parties said in a joint statement.
NIBRT will also maintain and license the database, expected to become available next year. Waters and NIBRT will co-market it worldwide.
Other terms were not disclosed.
The goal of the collaboration is to provide biopharmaceutical companies a "timely and powerful" tool for confirming the structures of glycosylated proteins. According to Waters and NIBRT, many protein-based biopharmaceuticals are glycosylated proteins, and the glycans can directly affect the efficacy and safety of glycoprotein biopharmaceuticals.
The database will give researchers "rapid and accurate" information about glycosylation during various stages of biopharmaceutical manufacturing, which in turn could lead to greater control over the manufacturing process in line with regulatory guidelines.
Factors such as dissolved oxygen, pH, carbon source, and temperature strongly influence protein glycosylation, and any change in these conditions can compromise the integrity of a biopharmaceutical. Consistent glycosylation is a "sensitive marker" of a well-controlled process, Waters and NIBRT said.
Correct glycosylation is essential for a protein to achieve and maintain its correct structure and therapeutic efficacy, they added.
"Our goal is to simplify and introduce more certainty into the process of analyzing glycans and making quality biomolecules," Jeff Mazzeo, director of Waters' biopharmaceutical business operations, said.
The database will be used with Waters' UPLC Glycan Solution for glycan structure assignment to each UPLC peak in order to confirm known structures present in a sample, or to look at Gu values and identify known and unknown glycans.
The UPLC Glycan Solution consists of the Acquity UPLC platform, the Acquity UPLC Fluorescence detector, UPLC BEH Glycan Technology columns, and instrument control software with MassLynx or Empower software.