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.

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

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.

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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.

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Biologics Explorer software

Be empowered with highly accurate and informative workflows for fully characterizing protein therapeutics and viral vector proteins.

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SCIEX OS software

Unleash the analytical power of the next-generation software platform for data acquisition and processing.

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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.

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X500B QTOF system

A purpose-built QTOF system, designed specifically to accelerate everyday biologics characterization.

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Biologics Explorer software

Be empowered with highly accurate and informative workflows for fully characterizing protein therapeutics and viral vector proteins.

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SCIEX OS software

Unleash the analytical power of the next-generation software platform for data acquisition and processing.

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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.

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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.

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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.

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