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.
Workflow
Enhanced MAM 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.
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Detect and flag the presence of unspecified impurities
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Confident differentiation of isomers
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Track known variants and contaminants
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Software templates optimized for peptide mapping and PQA selection
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Single software solution for PQA definition, monitoring, quantitation, purity testing and reporting
Enhanced MAM workflow
Solution
- PQA indentification
- Isomer differentiation and localization of PTMs
ExionLC AE system
ZenoTOF 7600 system
Biologics Explorer software
SCIEX OS software
Workflow
Streamlined MAM 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.
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Identify, track and quantify PQAs
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Monitor known impurities
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Detect and flag the presence of unspecified impurities
Streamlined MAM workflow
Solution
ExionLC AE system
X500B QTOF system
Biologics Explorer software
SCIEX OS software
All resources
A flexible solution for intact MAM offers a powerful workflow for ADC analysis
Electron-based fragmentation has been demonstrated to provide vital information that is key for complete molecule identification and characterization.
Gain advantages in data quality and time with a microfluidic chip-based integrated system that offers high-resolution and high-throughput separation of intact mAbs and their charge variants.
The single-injection EAD platform method allows differentiation of isomers and PTMs that are challenging for traditional characterization and MAM methods
Discover a platform workflow with the unique capability for isomer differentiation and localization of labile PTMs
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.
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.
Peptide analysis
Achieve new heights in PTM analysis with confidence and speed. Define critical quality attributes (CQAs) and streamline processes from early to late-stage development with in-depth peptide mapping solutions for next-generation protein therapeutics and standard monoclonal antibodies (mAbs).