UNIFI Scientific Information System
Waters UNIFI Scientific Information System is the first software platform to merge LC and high performance MS data (both quadrupole and time-of-flight) into a single solution that encompasses data acquisition, processing, visualization, reporting, and configurable compliance tools within a networked laboratory environment.
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21 CFR compliant.
Bopharmacutical characterization
UNIFI software is very user friendly. Data analysis, data acquisition happens in a single platform. Software has 21 CFR compliance so we can perform analysis used for regulatory filling.
Review Date: 10 Feb 2020 | Waters
By doing more projects using UNIFI, you're bringing more money into the copany for R&D research.
Biologics R&D
With UNIFI, you use one platform and it takes half the time of other software programs. I can save two or three days by using UNIFI to identify the candidates that are the most promising more quickly. That's a big benefit for our laboratory and the company.
Review Date: 26 Jun 2019 | Waters
Doing more projects using UNIFI brings more money into the company for R&D research.
Biologics R&D
With UNIFI, you use one platform and it takes half the time of other software programs. I can save two or three days by using UNIFI to identify the candidates that are the most promising more quickly. That’s a big benefit for our laboratory and the company.
Review Date: 8 Apr 2019 | Waters
Doing more projects using UNIFI brings more money into the company for R&D research.
Biologics R&D
With UNIFI, you use one platform and it takes half the time of other software programs. I can save two or three days by using UNIFI to identify the candidates that are the most promising more quickly. That’s a big benefit for our laboratory and the company.
Review Date: 20 Feb 2019 | Waters
The UNIFI platform enables a biopharmaceutical laboratory to comprehensively and routinely acquire, process, and report LC and MS characterization data throughout a biotherapeutic’s development lifecycle. From bioseparations to LC/MS characterization, the Waters Biopharmaceutical Platform Solution with UNIFI Software provides detailed workflows that enable results to be readily be shared from discovery to development to GxP quality control laboratories.
Whether you undertake advanced investigative work or execute routine methods, our platform will increase your confidence in results – confidence that you have obtained the best results for development decisions, and confidence that you have the information necessary to address to regulatory requirements.
At the heart of this unique platform is our new UNIFI Scientific Information System:
- UNIFI is the first software to merge LC and MS data in a single solution that encompasses data processing, visualization, reporting, and configurable compliance tools
- GlycoBase Database of glucose unit (GU) values is now integrated as a library within UNIFI, to streamline the analysis of glycoproteins, including the identification of glycan retention times and correlated glycan structures.
- Supports a mix of quadrupole time-of-flight (Q-Tof) MS and optical detection instruments within a laboratory network
- The ability to deploy UNIFI-based systems within regulated or non-regulated laboratory environments provides biopharmaceutical companies the flexibility to employ high resolution UPLC bioseparations and high performance mass analysis across the entirety of their development and quality organizations
- UNIFI's data mining and comparison capabilities enhance your ability to understand results with an unparalleled ability to aggregate and manage information
The making of a modern biopharmaceutical
In this white paper, Waters Corporation discusses the future trends in the biopharmaceutical industry including multi attribute monitoring (MAM), biophysical analysis as a complement to analytical characterization, and the rise of mass detection as a foundational technology.
Improved productivity with integrated peptide attribute profiling and monitoring workflow
This application note demonstrates the peptide mapping and monitoring capabilities of the BioAccord System using the forced degradation of a monoclonal antibody as a case study.
Increase productivity for N-linked glycan analysis of biosimilars
This application note demonstrates how the BioAccord can increase confidence and productivity in released glycan analysis for the development of biosimilars.
A direct IEX-MS method for the detection of mAb charge variants
This application note demonstrates a direct IEX-MS method with broad utility for the successful detection of mAb charge variants. Platform methods can be easily developed using the BioResolve SCX mAb Column, IonHance CX-MS pH Concentrates, and BioAccord LC-MS System which provide robust and reproducible separations along with high quality mass spectra in the elucidation of various mAb-charge variant species.
Practical considerations for optimizing MS quality during IEX-MS
When it comes to optimizing MS quality in an IEX-MS analysis, considerations need to be made around mobile phases, labware, and reagent quality at all levels. The use of IonHance CX-MS buffers, the substitution of non-volatile salts during sample preparation steps, and the replacement of glass for certified thermoplastics can lead to substantive improvements in spectral quality. This application note demonstrates the benefits of using MS-grade reagents, certified plasticware, and tai
Compliant-ready workflow for mass confirmation of oligonucleotides
Waters UNIFI™ Scientific Information System is the first compliance-ready software platform to merge LC and high performance MS data into a single solution that encompasses data acquisition, processing, visualization and reporting. It supports a wide range of biotherapeutic workflows, including mass confirmation of synthetic oligonucleotides and their related impurities. This poster presents the automated data processing and reporting workflow for oligonucleotides using an oligonucleotide standard mixture.
Integrated UPLC-FLR-HRMS system for N-linked glycan analysis
This scientific poster demonstrates in-line HRMS detection that enables an efficient LC-FLR/MS workflow with increased productivity and confidence for released glycan analysis in biotherapeutics development.
Automated Monoclonal Antibody Modification with Waters UNIFI Scientific Information System
In this application note, Waters demonstrates how the UNIFI Scientific Information System can be used to tackle the challenge of data processing in monoclonal antibody (mAb) modification analysis, using the NIST mAb reference material as a relevant test case. When used in conjunction with the Vion IMS QTof mass spectrometer, the UNIFI system promises to control data acquisition, data processing and reporting, providing an end-to-end platform for probing a variety of mAb modifications with high confidence.
Ion Mobility-Enabled Data-Dependent Experiments Distinguishing Co-Eluting Isomeric Metabolites Using an IMS-QTof Mass Spectrometer
LC-MS/MS using data-dependent acquisition (DDA) is widely used for characterization of metabolites in drug metabolism studies. In this application note, nefazodone was incubated with rat hepatocytes and analyzed using both DDA and IMS-enabled DDA and co-eluting metabolites were characterized.
Harnessing the Efficiency of Nitrogen Carrier Gas with the Atmospheric Pressure Gas Chromatography (APGC) Source
Helium is the most commonly used carrier gas in gas chromatography, however, finite reserves results in periodic price increases and concern of availability. Nitrogen is a more affordable alternative. This application note highlights the ease of implementing nitrogen as a replacement carrier gas for helium in GC separations, illustrating a cost-effective approach for atmospheric pressure MS sources, while maintaining critical separations and chromatographic performance.
How GSK’s Method Innovation team is leading new efficiencies in biopharmaceutical molecule development
Read how GSK’s Method Innovation team is evaluating new technologies to drive efficiency in biopharma molecule development, in this exclusive interview
Waters Expands Accessibility to High Resolution MS Data with the First SmartMS-Enabled LC-MS Biopharma System
As the number of analytical monitoring tests for biopharmaceuticals skyrockets, Waters builds intelligence into a fit-for-purpose system
