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.
Multi-attribute methodology
-
Webinar
Dig deeper and identify new PQAs
Learn about the link between glycation and color change in final drug products along with how to develop assays for rapid monitoring and tracking of these PTMs.
-
Document
Cut out risk, cut out information gaps
Charge ahead with charge variant analysis and proteoform identification in minutes on a single platform with the new Intabio ZT system.
Overview
Establishing multi-attribute methodology (MAM) in biotherapeutic process development streamlines the evaluation and monitoring of potential PQAs that are crucial to ensuring quality, safety and efficacy.
Regulatory requirements continue to evolve and expand, increasing the pressure to provide more detailed information on a biotherapeutic. There is a need to reduce the amount of resources required to collect this information, but gain an even deeper understanding of the therapeutic.
Directly monitor multiple PQAs in single LC-MS assays with MAM solutions designed to address next generation drug development.
Enhanced MAM workflow
Workflow
Embrace the multitasking power of MAM with confident identification of PQAs and unambiguous differentiation of their isomers. Turbocharge your MAM workflows with a faster, more in depth view of your biologic by leveraging the power of electron activated dissociation (EAD) and gain comprehensive characterization at both the intact protein and peptide level from a single injection. A streamlined data flow creates a single software solution connecting peptide mapping results with PQA quantitation and monitoring with compliant-ready software.
- Detect and flag the presence of unspecified impurities
- Confident differentiation of isomers
- Track known variants and contaminants
- Software templates optimized for peptide mapping and PQA selection
- Single software solution for PQA definition, monitoring, quantitation, purity testing and reporting
Resources
-
Technical note
Confident PQA identification and differentiation of isomers
The single-injection EAD platform method allows differentiation of isomers and PTMs that are challenging for traditional characterization and MAM methods
-
Technical note
EAD based MAM for enhanced characterization and monitoring of PQAs
Discover a platform workflow with the unique capability for isomer differentiation and localization of labile PTMs
Enhanced MAM workflow
Suited for:
- PQA indentification
- Isomer differentiation and localization of PTMs
ExionLC AE system
Reproducibility, reliability and carryover performance to match your quantitative workflows. Dependability you can count on, from injection to injection and batch after batch.
Learn more
ZenoTOF 7600 system
A high-resolution mass spectrometry solution that combines powerful MS/MS sensitivity, fragmentation technology and a step-change in data independent acquisition.
Learn more
Biologics Explorer software
Be empowered with highly accurate and informative workflows for fully characterizing protein therapeutics and viral vector proteins.
Learn more
SCIEX OS software
Unleash the analytical power of the next-generation software platform for data acquisition and processing.
Learn more
Streamlined MAM workflow
Workflow
Gain direct physical information about the most important product quality attributes. Simplified setup for accelerated results in a compact footprint provides a solution for simplified PQA definition, monitoring, quantification and reporting.
- Identify, track and quantify PQAs
- Monitor known impurities
- Detect and flag the presence of unspecified impurities
Streamlined MAM workflow
Suited for:
- Simplified MAM protocols
- Streamlining routine characterization
ExionLC AE system
Reproducibility, reliability and carryover performance to match your quantitative workflows. Dependability you can count on, from injection to injection and batch after batch.
Learn more
X500B QTOF system
A purpose-built QTOF system, designed specifically to accelerate everyday biologics characterization.
Learn more
Biologics Explorer software
Be empowered with highly accurate and informative workflows for fully characterizing protein therapeutics and viral vector proteins.
Learn more
SCIEX OS software
Unleash the analytical power of the next-generation software platform for data acquisition and processing.
Learn more
All resources
Filter:
-
Technical note
Enable faster decision making in process development
A flexible solution for intact MAM offers a powerful workflow for ADC analysis.
-
Document
EAD - A new paradigm for mass spectrometry
Electron-based fragmentation has been demonstrated to provide vital information that is key for complete molecule identification and characterization.
-
Technical note
Confident separation and identification of proteoforms
Gain advantages in data quality and time with a microfluidic chip-based integrated system that offers high-resolution and high-throughput separation.
-
Technical note
Confident PQA identification and differentiation of isomers
The single-injection EAD platform method allows differentiation of isomers and PTMs that are challenging for traditional characterization and MAM methods.
-
Webinar
EAD based MAM for enhanced characterization and monitoring of PQAs
Discover a platform workflow with the unique capability for isomer differentiation and localization of labile PTMs.
-
Brochure
MAM with confidence and compliance
The powerful, yet straightforward, SCIEX workflow for MAM offers a compliant and flexible solution for simplified PQA definition, monitoring, quantitation and reporting.
Associated applications
Subunit mass analysis and middle-down
Take control of the unknowns. Gain confident sequence confirmation and localization of post-translational modifications (PTMs) at the sub-unit level.
Learn more
Intact protein analysis
Confidently select lead candidates and ensure reproducible product quality. Discover fast and reliable solutions that simplify identification and characterization of complex molecules at the intact level.
Learn more
Peptide analysis
Achieve new heights in PTM analysis with confidence and speed. Define CQAs and streamline processes from early to late-stage development with in-depth peptide mapping solutions for next-generation protein therapeutics and standard mAbs.
Learn more