Waters and PREMIER Biosoft to Co-Market Data Analysis Software for Glycan Characterization

Waters Corporation (WAT:NYSE) today announced it has entered into an agreement with PREMIER Biosoft International (Palo Alto, CA) to co-market the firm’s SimGlycan^® Software with Waters mass spectrometry solutions for glycan and glycopeptide analysis. Under the terms of the agreement, Waters will continue to sell and support its mass spectrometry-based glycan analysis solutions, while PREMIER Biosoft will market its software to customers analyzing glycans and glycopeptides on both the Waters SYNAPT™ and XEVO™ mass spectrometry platforms.

By augmenting Waters separations science products, mass spectrometers, and UltraPerformance LC^® (UPLC^®) chemistries with PREMIER Biosoft’s SimGlycan data analysis software, biopharmaceutical manufacturers can obtain business-critical information critical for understanding biotherapeutic stability and safety.

The Importance of Glycosylation Attracts Regulatory Oversight

Glycans are branching polymeric sugar molecules that are attached to biopharmaceuticals – proteins, peptides, monoclonal antibodies – following protein translation. The final result of glycan addition and maturation reactions within the cell is a heterogeneously modified biotherapeutic where the various glycosylated forms can differentially affect the efficacy and safety profile of the biopharmaceutical product. Determination of the sites of glycan attachment on the protein and the population of glycans that are present at each site are required for both therapeutic and safety assessments. The complexity of all possible glycan structures places tremendous demands on the analytical techniques used for their analysis. Yet, consistency of glycosylation is routinely used as a sensitive marker for demonstrating control of the biotherapeutic production process. The U.S. Food and Drug Administration, and other regulatory agencies, have handed down guidance requesting stricter control of product glycosylation, leading to greater industry investment in analytical techniques that promise to facilitate a better understanding of these complex biotherapeutic drug products.

About Waters UPLC Glycan Analysis Solution

The Waters UPLCGlycan Analysis Solution comprises an ACQUITY UPLC BEH Glycan Separation Technology column optimized for use with the ACQUITY UPLC^® System together with fluorescence detection (FLR) to separate the released glycans of biopharmaceuticals as their 2-aminobenzamide (2-AB) or other fluorescent derivatives. The UPLC Glycan Separation Solution provides robust, high-resolving, reproducible, and rapid methods that out-perform analyses by HPLC. The high resolving power and sensitivity of the UPLC Glycan Solution allows laboratories to separate and detect isobaric isomers (same mass, different retention time), a wide range of glycans – high mannose, neutral and sialylated – and low abundant glycans – those present in very small concentrations relative to other glycans.

The UPLC Glycan Solution coupled with Waters mass spectrometers provides additional structural confirmation of the glycans.

As an MS/MS data analysis tool, SimGlycan software predicts the glycan structure on a protein molecule, scores it and generates a list of probable glycans that closely match the given MS profile. The SimGlycan database is a large relational database containing 8,553 glycans and the database is continuously updated as information on additional glycans is published. Both glycopeptide and released glycan profiles are supported.

About PREMIER Biosoft International (www.premierbiosoft.com)

Founded in 1994, is led by computer scientists and biologists dedicated to producing cutting edge intuitive software for research in life sciences. The company’s goal is to study the most recent innovations in life sciences and translate them into software products to aid research.

About Waters Corporation (www.waters.com)

For more than 50 years, Waters Corporation (NYSE:WAT) creates business advantages for laboratory-dependent organizations by delivering practical and sustainable innovation to enable significant advancements in such areas as healthcare delivery, environmental management, food safety, and water quality worldwide.

Pioneering a connected portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis, Waters technology breakthroughs and laboratory solutions provide an enduring platform for customer success.

With revenue of $1.5 billion in 2009 and 5,200 employees, Waters is driving scientific discovery and operational excellence for customers worldwide.