Biopharmaceutical Platform Solution with UNIFI
The Waters Biopharmaceutical Platform Solution with UNIFI® integrates robust UPLC®/MS characterization technology with the UNIFI Scientific Information System for applications in bioseparations, intact protein mass analysis, peptide mapping and released glycan analysis.This platform unites all aspects of biotherapeutic analyses and workflows, enabling organizations to apply high resolution analytics across the development proc…
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The Waters Biopharmaceutical Platform Solution with UNIFI® integrates robust UPLC®/MS characterization technology with the UNIFI Scientific Information System for applications in bioseparations, intact protein mass analysis, peptide mapping and released glycan analysis.
This platform unites all aspects of biotherapeutic analyses and workflows, enabling organizations to apply high resolution analytics across the development process continuum. The platform captures complex mass spectrometry and chromatography data, and enables laboratories to comprehensively and routinely acquire, process, and share LC and MS characterization information throughout a biotherapeutic’s lifecycle. Results can be shared from discovery to development to GxP quality control.
Released N-linked Glycan Analysis Using the Glycan Application Solution with UNIFI
This application note from Waters Corporation aims to demonstrate two fit-for-purpose glycan analysis workflows for comprehensive N-linked glycan profiling and structural elucidation within the Waters® Glycan Application Solution with UNIFI.
Structural Comparison of Infliximab and a Biosimilar via Subunit Analysis Using the Waters Biopharmaceutical Platform with UNIFI
This application note characterizes infliximab and a biosimilar candidate, produced in a different cell line, using Waters Biopharmaceutical Platform Solution. The objective is to screen multiple lots of both the innovator and biosimilar products at the subunit level to establish comparability at this higher level of structure. Lot-to-lot and batch-to-batch comparisons will show product variation, illustrating the range of quality attributes to be considered in a candidate biosimilar.
A Holistic Workflow for Acquisition, Processing, and Reporting Fluorescent-Labeled Glycans using the Biopharmaceutical Platform Solution with UNIFI
Learn how the Waters Biopharmaceutical Platform solution with UNIFI streamlines analytical workflows for glycans and increases productivity within the biopharmaceutical manufacturing process.
Simultaneous Determination of Molecular Size, Concentration, and Impurity Composition of Biotherapeutics with SEC and the Biopharmaceutical Platform Solution with UNIFI
The objective of this application note is to demonstrate the ability to determine molecular weight and amount of the constituents of an antibody sample using UNIFI informatics. A purified antibody from human serum was used as a model protein to test the application.
N-linked Glycan Characterization and Profiling: Combining the Power of Accurate Mass, Reference Glucose Units, and UNIFI Software for Confident Glycan Assignments
This application note details a new workflow for a glycan assay, using FLR with mass confirmation, available in the latest version of the Biopharmaceutical Platform Solution with UNIFI. The practical use of this workflow for fluorescent labeled (2AB) N-linked released glycan characterization is illustrated using a biosimilar/innovator biotherapeutic comparability study.
Streamlining and Non-Compliant Intact Mass Analysis of Biotherapeutic mAbs with the Biopharmaceutical Platform Solution
The Biopharmaceutical Platform Solution with UNIFI® enables a fully integrated workflow for intact mass analysis, including acquisition, processing, and reporting, for organizations in early development and those operating under regulatory compliant environments. The ability to automate and standardize intact mass analysis enables laboratories to deploy their scientific resources with greater efficiency and effect.
Analysis of Antibody Drug Conjugates
As biopharmaceutical organizations explore the use of Antibody Drug Conjugates (ADC) as a class of cancer therapies, significant challenges are found in analyzing their complex, heterogeneous structures. The determination of drug-to-antibody ratios (DAR) and sites of conjugation presents unique analytical challenges that can be addressed with Waters' fit-for-purpose UPLC, QTof MS, and informatics solutions.
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 New HILIC-based Glycoprotein Column Enhances Glycan Analysis
Provides glycan occupancy information for biotherapeutic glycoproteins
