The Glycan Application Solution with UNIFI features an extensive N-glycan Glucose Unit (GU) reference database that was developed in collaboration with the National Institute for Bioprocessing Research and Training (NIBRT). The Waters Glycan GU Library, used along with Waters’ robust and bioseparations-focused analytical technologies to characterise glycosylation, enables biopharmaceutical laboratories to deliver well-characterised biotherapeutics from discovery through development and QC operations. The solution facilitates routine assignment of N-linked glycan structures, and enables profiling of released glycans for individual sample analysis and expedites multi-batch comparability studies for either innovator biotherapeutics or biosimilars. The system solution consists of the ACQUITY UltraPerformance LC (UPLC) H-Class System, an ACQUITY UPLC Fluorescence (FLR) Detector, the Xevo G2-S QTof Mass Spectrometer, Waters’ application-tested bioseparation column chemistries, and analytical glycan standards used for system familiarisation training, GU-retention time calibration and routine glycan system function checks. This new Glycan Application Solution with UNIFI complements intact protein analysis and peptide mapping applications that are also available within the Biopharmaceutical Platform Solution with UNIFI.
Waters Forensic Toxicology Screening Application Solution with UNIFI was devised with direct input from forensic scientists within active forensic toxicology laboratories. A complete toxicology solution, the platform integrates chromatography method, mass spec and software to enable a robust, end-to-end solution that requires minimal or no method development. The software includes a comprehensive database of compounds of toxicological interest which can easily be extended to address ‘unknown’ analytes that may be germane to the evidence. Furthermore, UNIFI reporting capabilities present forensic sample analysis results in a meaningful and relevant manner to improve the forensic laboratory workflow, output and turnaround time. Lastly, the UNIFI software security is well tailored to meet the stringent chain-of-custody standards of forensic toxicology laboratories. In addition to the UNIFI software platform, the application solution consists of the ACQUITY UltraPerformance LC (UPLC) I-Class, the Xevo G2-S QTof mass spectrometer and Waters’ application-tested HSS column chemistries.
Also built upon the Waters Screening Platform Solution, the Natural Products Application Solution with UNIFI enables laboratories to readily move from sample extract to product knowledge using a sensitive and accurate-mass analytical platform integrated with fit-for-purpose workflows and reporting. The solution features a ‘Traditional Medicines’ library including all the herbs detailed in the 2010 Chinese Pharmacopeia. The integration of data acquisition and processing with the Traditional Medicine library provides a simple, efficient process to effectively facilitate the identification and comparison of chemical ingredients from complex natural product samples. This greatly improves productivity and reduces the demands for operator’s technical expertise level. The application solution consists of the ACQUITY UltraPerformance LC (UPLC) I-Class System, an ACQUITY UPLC TUV Detector, the Xevo G2-S QTof mass spectrometer, Waters’ application-tested High Strength Silica (HSS) column chemistries and application-specific analytical standards.
These three new application solutions can be deployed and configured to meet the needs and offer unique UNIFI capabilities to multi-user, server-based workgroups for the capture, storage, and management of analytical LC, LC/MS, and LC/MS/MS data. Additionally, UNIFI manages and stores exponentially larger dataset files with improved robustness, performance and processing speed which is a major step forward for advancing UNIFI as an enterprise-wide Scientific Information System. From data acquisition to advanced interpretation and reporting, UNIFI comprehensively streamlines scientific workflow.
In addition to the UNIFI three application solutions mentioned, Waters offers the following five system solutions as well:
The existing Biopharmaceutical Platform Solution with UNIFI platform, enabling the deployment of high-resolution UPLC or UPLC/QTof-MS analytics across the innovator biotherapeutic or biosimilar development process.
Regulated Bioanalysis Platform Solution with UNIFI is an LC/MS/MS system for drug metabolism and pharmacokinetic (DMPK) organisations and CROs that combines the latest in sample preparation, UPLC and chemistries, and tandem quadrupole mass spectrometry.
Screening Platform Solution with UNIFI is the first and only comprehensive screening solution to target, identify, quantify and review based on a streamlined analytical workflow that enables more accurate results across a variety of applications. The holistically designed Platform Solution consists of the ACQUITY UPLC I-Class, the Xevo G2-S QTof mass spectrometer, Waters Analytical Standards & Reagents and Waters Chemistries.
Pesticide Screening Application Solution with UNIFI delivers the ease-of-use, sensitivity, stability, reproducibility, and throughput scientists need to successfully and profitably perform pesticide residue screening in a manner compliant with regulatory requirements today and in the future.
Metabolite Identification Application Solution with UNIFI is the world’s most comprehensive metabolite identification system assisting the DMPK scientist in identifying and characterising metabolites in both discovery and development environments. Chemically intelligent yet flexible workflows are at the core of UNIFI’s design. The workflow approach integrates both quantitative and qualitative datasets and workflows into a single analysis.
With its comprehensive portfolio of chromatography, mass spectrometry, informatics, and chemistry technologies, Waters is uniquely positioned to develop end-to-end solutions that make otherwise challenging applications routine.
EP News Bureau – Mumbai