Overview
Reclaim your time for innovation with solutions for intact protein analysis that inform decision-making and reduce risk throughout the development pipeline.
One of the challenges with intact protein analysis is the lack of a high-resolution separation approaches that couple to mass spectrometry. As a result, mass spectrometry adoption tends to occur more in the later stages of early development, after candidates have been narrowed down by other methodologies. This approach provides less qualitative information, however.
When bringing new modalities to market, including new and complex next-generation therapies, there is a need to gain critical information and greater insight during early development in order to reduce risk downstream.
Solutions for comprehensive intact biotherapeutic analysis enable confident selection of lead candidates during early-stage development and continued monitoring of product quality attributes through to commercialization.
Workflow
Rapid comprehensive intact protein analysis
Acquire multiple pieces of critical data from your intact protein analysis workflow.
Leverage the high-resolution separation capabilities of imaged capillary isoelectric focusing (icIEF) and gain greater perspective by collecting heterogeneity information on multiple samples.
The combination of icIEF separation, with UV quantitation and mass spec identification provides high-resolution separation and comprehensive characterization of intact monoclonal antibodies (mAbs) and their charge variants in a single assay, on a single platform. Obtain this critical information earlier in the development process and inform better decision making.
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Reproducible separation and analysis of charge variants in minutes
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Accurate characterization of charge variant peaks by MS
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Identification of proteoforms and their PTMs at the intact level
Single-platform proteoform identification
Solutions
- Rapid multi-attribute monitoring of intact protein therapeutics
- Comprehensive characterization of intact protein therapeutics
Intabio ZT system
Biologics Explorer software
Workflow
High-throughput intact protein analysis
Confirm drug identity, monitor product quality and perform comparative studies with a high-throughtput LC-MS workflow.
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Rapid screening without time-consuming manual operations
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Intuitive data visualization for more confident screening and selection
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Achieve consistent annotation of intact LC-MS data
Solutions
High-throughput intact protein analysis
- High throughput screening assays
- Rapid product identification
ExionLC AE system
ZenoTOF 7600 system
Biologics Explorer software
All resources
Highly confident identification of CQAs with an integrated icIEF-UV/MS solution that identifies low abundant PTMs at the intact protein level.
Gain advantages in data quality and time with an integrated system that offers high-resolution and high-throughput separation of intact mAbs and their charge variants.
A single platform icIEF-UV/MS workflow offers high sensitivity and selectivity to detect low-abundant proteoforms that could impact product quality.
Comprehensive characterization and identification of the charge variants of deglycosylated NISTmAb in minutes.
Enable high-throughput screening of intact proteins and close the data gap with intuitive software workflows.
Reduce charge heterogeneity analysis from weeks to minutes. Identify and monitor the charged modification on ADC payloads in near real-time.
Probe the cause of color change in protein therapeutics and learn how a cell line development group is utilizing the integrated icIEF-UV/MS workflow to monitor advanced glycation events for product release.
Associated applications
Charge heterogeneity analysis
Pursue the end goal with confidence. Achieve the full picture and accelerate decisions with comprehensive characterization of biopharmaceutical charge variants.
Multi-attribute methodology
Pursue simpler, faster and more accurate product quality profiles. Reclaim time for innovation and reduce overall analytical testing burden with software solutions for product quality attribute (PQA) monitoring.