Waters has developed a Biopharmaceutical System Solution which will bring together Ultra Performance Liquid Chromatography (UPLC) and Mass Spectrometry (MS) characterization technology with UNIFI Scientific Information System. This is an industry first comprehensive software solution that unites all aspects of biotherapeutic analyses and workflows for high-resolution analytics across the development process continuum.

The combination of Ultra Performance Liquid Chromatography, mass spectrometry and bioinformatics technologies results in efficient flow of data and information and conforms to biopharmaceutical quality guidelines and regulations.

The Biopharmaceutical System Solution includes: acquity UPLC H-Class Bio System featuring a bio-inert flow path and quaternary solvent management with Auto Blend Plus Technology, for flexibility in executing high-resolution bio-separations.  The company’s Peptide and Protein Separation Technology Columns engineered with the selectivity to leverage the characteristics of bio-molecules and QC-tested to ensure consistent results.

Xevo G2 Tof Mass Spectrometer is the most sensitive exact-mass quantitative and qualitative benchtop MS system designed with Engineered Simplicity. The UNIFI Scientific Information System is an interactive workflow-driven data platform for flexible instrument control, advanced data processing and mining and comprehensive reporting, with GxP laboratory compatibility that enables routine deployment throughout your organization.

“Waters is now the first to offer biopharmaceutical scientists a total system for protein characterization using high-end mass spectrometry that supports Good Manufacturing Practices regulations (GMP) that biopharmaceutical companies are required to comply with,” said Jeff Mazzeo, director, Biopharmaceutical Business Operations, Waters Division.
“In addition to being able to operate in a GxP compliant environment, the new Biopharmaceutical System allows customers to extract and share the maximum amount of information. For example, when a scientist develops a peptide map in the discovery laboratory, all of the methods and reports generated can be shared with colleagues down the line in the Quality Control (QC) laboratory leading to significant productivity gains. UNIFI is the common platform that allows customers to share information in a much more efficient manner than previously possible,” he added.

Focused on task-specific workflow design, the Biopharmaceutical System features automated data processing and simplified results validation. Critical to biopharmaceutical organizations is reliance on an analytical system that supports GMP and compliance tools, such as electronic signatures and user authentication, all with underlying secure database technology. The Biopharmaceutical System is scalable to use as a workstation with the ability to expand to workgroup and enterprise deployments.

With the scalability and flexibility built into the system, customers can anticipate benefits from the Biopharmaceutical System, he said.