Multi-Attribute Analyses

Multi-Attribute Analyses

Partner with Waters to streamline your characterization and routine monitoring of biotherapeutics through multi-attribute analyses, building more comprehensive product knowledge to develop safer therapeutics, faster.

Partner with Waters to streamline your characterization and routine monitoring of biotherapeutics through multi-attribute analyses, building more comprehensive product knowledge to develop safer therapeutics, faster.
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Expert perspectives on the adoption of LC-MS based attribute analysis for biopharmaceuticals
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Overview

The adoption of LC-MS-based multi-attribute method (MAM) analysis and Multi-Angle Light Scattering (MALS) techniques for monitoring of biotherapeutic variation has progressed greatly over recent years. Directly assessing molecular attributes contributing to efficacy, safety, stability, and process robustness enables organizations to obtain more data without the ambiguity of traditional assays.

Often, this data is generated with greater sensitivity and dynamic range than legacy assays, complementing or eventually replacing these traditional analyses in development, manufacturing, and quality organizations. Waters systems, software, consumables, and automation support the analysis of multiple biopharmaceutical attributes, from characterization to routine monitoring.

Applications

Peptide MAM allows for routine monitoring of therapeutic variation with a single LC-MS method, complementing or replacing a traditional multi-method approach. Learn about Waters expertise and workflows for fast, simple routine MAM implementation.

Peptide MAM allows for routine monitoring of therapeutic variation with a single LC-MS method, complementing or replacing a traditional multi-method approach. Learn about Waters expertise and workflows for fast, simple routine MAM implementation.

Application Notes

Intact protein and subunit MAM complement peptide MAM approaches in biopharmaceutical development. Peptide MAM methods provide highly targeted capability but are challenged by laborious sample preparation, longer run times, and complex data analysis. These alternative approaches address these challenges, while also providing an opportunity to monitor a wide range of biotherapeutic product attributes.

Intact protein and subunit MAM complement peptide MAM approaches in biopharmaceutical development. Peptide MAM methods provide highly targeted capability but are challenged by laborious sample preparation, longer run times, and complex data analysis. These alternative approaches address these challenges, while also providing an opportunity to monitor a wide range of biotherapeutic product attributes.

Application Notes

Light scattering techniques provide robust in-solution monitoring, allowing simultaneous measurement of molecular weight, size, and concentration. Gain insight into aggregation, oligomer stoichiometry, and composition of complex molecules such as glycoproteins. Monitor during purification in real time to boost quality and yield or integrate with Waters LC systems.

Light scattering techniques provide robust in-solution monitoring, allowing simultaneous measurement of molecular weight, size, and concentration. Gain insight into aggregation, oligomer stoichiometry, and composition of complex molecules such as glycoproteins. Monitor during purification in real time to boost quality and yield or integrate with Waters LC systems.

Application Notes

Application Notebook: Multi-Attribute Methods for Biopharmaceutical Analysis

The utilization of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation delivers valuable measurements to biopharmaceutical scientists. This notebook is a compilation of application notes generated by the Biopharmaceutical Scientific Operations team at Waters. They illustrate key attribute monitoring workflows that have been developed to improve and streamline MAM analysis of biotherapeutic proteins.

The utilization of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation delivers valuable measurements to biopharmaceutical scientists. This notebook is a compilation of application notes generated by the Biopharmaceutical Scientific Operations team at Waters. They illustrate key attribute monitoring workflows that have been developed to improve and streamline MAM analysis of biotherapeutic proteins.
Download Application Notebook
Methods for biopharmaceutical anaysis

Solutions

Waters LC and LC-MS systems offer leading separations performance and sensitivity for multi attribute analysis.

Waters LC and LC-MS systems offer leading separations performance and sensitivity for multi attribute analysis.

Efficient product attribute monitoring throughout development

Efficient product attribute monitoring throughout development
BioAccord LC-MS System

Enable LC-MS biopharmaceutical analyses in every GxP lab with Waters BioAccord LC-MS System, including high-resolution MS and waters_connect software for compliance-ready data analysis and reporting.

  • Peptide MAM
  • Intact and Subunit MAM

Complete high-resolution capability for confident characterization and method transfer

Complete high-resolution capability for confident characterization and method transfer
Xevo G3 QTof

Accelerate multi attribute characterization and monitoring with the Xevo G3 QTof high-performance HRMS benchtop system, delivering accurate qualitative and quantitative results.

  • Peptide MAM
  • Intact and Subunit MAM

Ultra-low adsorption for maximum sensitivity and reproducibility

Ultra-low adsorption for maximum sensitivity and reproducibility
MaxPeak Premier Solutions

Eliminate the unpredictability of analyte losses due to metal interactions, which can be especially pronounced with biological molecules, using MaxPeak Premier columns and systems.

  • Peptide MAM
  • Intact and Subunit MAM

Uniquely versatile detector for every developmental stage

Uniquely versatile detector for every developmental stage
DAWN

Gain vital assistance at every development stage with the DAWN MALS detector. Couple with Eclipse to measure binding affinity during discovery. Place downstream of any LC and perform advanced analysis of protein-conjugate ratio, oligomerization, and aggregation.

  • Multi Attribute Quantitation

Increase yield and monitor product quality with confidence

Increase yield and monitor product quality with confidence
ultraDAWN

Directly monitor molecular weight, size, and impurities in real time with ultraDAWN that connects downstream of any purification and enrichment method, such as IEX, FPLC, or TFF.

  • Multi Attribute Quantitation

Separate beyond question with the power of mass detection

Separate beyond question with the power of mass detection
ACQUITY QDa II Mass Detector

Take single quadrupole performance to the next level. Monitor targeted attributes with the ACQUITY QDa II Mass Detector, which is easy to use and remarkably robust.

  • Peptide MAM

Compliance-ready, networkable applications-based software to streamline LC-MS data acquisition, processing, and reporting.

Compliance-ready, networkable applications-based software to streamline LC-MS data acquisition, processing, and reporting.

Streamline data analysis and processing

Streamline data analysis and processing
waters_connect for biopharmaceuticals

Accelerate the journey from sample analysis to decision-making with waters_connect for biopharmaceuticals that offers dedicated apps and workflows for MAM, intact mass analysis, sequence confirmation, and more.

  • Peptide MAM
  • Intact and Subunit MAM

Achieve quick, clean and complete protein digestion

Achieve quick, clean and complete protein digestion
RapiZyme Trypsin, Mass Spectrometry (MS) Grade

Achieve quick, clean, and complete mAb digestions in just 30 minutes with RapiZyme Trypsin, Mass Spectrometry (MS) Grade, a highly active autolysis-resistant enzyme that reduces the likelihood of artificial modifications occurring during sample preparation prior to LC-MS analysis.

  • Peptide MAM
  • Tryptic Digestion
  • Protein Digestion
  • Peptide Mapping

Streamline peptide MAM sample preparation

Streamline peptide MAM sample preparation
PeptideWorks Tryptic Protein Digestion Kits

Achieve high efficiency, reproducible peptide maps in under 2.5 hours with PeptideWorks Tryptic Protein Digestion Kits for manual or automated workflows that are 4x faster than average home-brew methods and provide a 78% reduction in missed cleavages.

  • Peptide MAM
  • Tryptic Digestion
  • Protein Digestion
  • Peptide Mapping

Maximize sensitivity while minimizing metal adsorption of acidic deamidated peptides

Maximize sensitivity while minimizing metal adsorption of acidic deamidated peptides
MaxPeak Premier Peptide Columns

Gain enhanced recovery and sensitivity for acidic peptides with Waters ACQUITY, XSelect, and XBridge Premier Peptide Columns that are QC batch-tested with Waters Cytochrome c Digest Standard for increased column-to-column performance consistency. 

  • Peptide MAM
  • Tryptic Digestion
  • Protein Digestion
  • Peptide Mapping
  • Reversed-Phase Peptide Columns

Reversed-phase solutions for intact and ideS digested mAbs

Reversed-phase solutions for intact and ideS digested mAbs
BioResolve RP mAb Polyphenyl Columns

Characterize intact and subunit protein analysis of mAbs, ADCs, and bio-conjugates with BioResolve RP mAb Polyphenyl Columns for better resolution at higher flow rates and maximum resolving power and selectivity of analyzed protein samples.

  • Peptide MAM
  • Intact and Subunit MAM
  • Reversed-Phase Intact Columns
  • Reversed-Phase Subunit Columns

Gain efficiency and walk away time with verified lab automation solutions.

Gain efficiency and walk away time with verified lab automation solutions.

Enhance sample prep efficiency and throughput

Enhance sample prep efficiency and throughput
Laboratory Automation and Equipment

Streamline sample preparation for LC-MS analyses with Waters Laboratory Automation and Equipment that deliver verified workflows to help minimize variability, improve traceability, and simplify method transfer.

  • Peptide MAM
  • Intact and Subunit MAM

Your success is just a click away

Your success is just a click away
Waters Global Services

Optimize your laboratory's productivity and success with Waters Global Services to maintain peak system performance, minimize down time, address application challenges, and support stringent compliance requirements.

  • Peptide MAM
  • Intact and Subunit MAM
  • Multi Attribute Quantitation

Make science more accessible with Waters Capital

Make science more accessible with Waters Capital
Payment Solutions

Maximize resources and minimize risk with payment options from Waters Capital, including upgrading aging equipment, getting customized support, and bundling services into one monthly payment.

  • Peptide MAM
  • Intact and Subunit MAM
  • Multi Attribute Quantitation

The data speaks for itself

The data speaks for itself
Bar graphs showing results presented in the Peptide MAM App for four monitored attributes, C-terminal Lysine, HT02 oxidation, HT07 oxidation, and HT03 deamidation. Injections are labeled as 1–3 for Remicade, 4–6 for Inflectra, 7–9 for Avsola, and 10–12 for Renflexis.
Peptide MAM App: New Peak Detection performed with defined criteria based on fold change, %base peak level, %isotopic similarity and retention time tolerance. Each peak passing the criteria (Right Side) is displayed for review. The peaks can be further examined using MS spectra to manually verify the NPD results.
Peptide MAM App: A monitored attribute peptide panel (%Abundance) is displayed for three modified (oxidized, deamidated, and glycosylated) peptides. Predefined pass/fail criteria based on user defined limits determine the color of bars, and the presence of a warning icon above them. The table, below, displays target criteria and results for the DTLMISR Ox attribute.
Selected product quality attributes for Remicade (infliximab) and three biosimilars subjected to thermal stress (all digested with RapiZyme Trypsin), T0, T1 (1 week), and T2 (2 weeks). Injections 1–3=Remicade (infliximab), 4–6=Inflectra (infliximab), 7–9=Avsola (infliximab), and 10–12=Renflexis (infliximab).

Webinars and Resources

  • Application Notebook

Multi-Attribute Methods for Biopharmaceutical Analysis

Multi-Attribute Methods for Biopharmaceutical Analysis
Download
  • eBook

Multi-Attribute Methods eBook

Multi-Attribute Methods eBook
Download
  • Infographic

Protein and Peptide Attribute Monitoring Workflows

Protein and Peptide Attribute Monitoring Workflows
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  • On Demand Webinar

Multiple-Attribute Analyses (MAA) at Peptide or Subunit Levels: Ready for QC

Multiple-Attribute Analyses (MAA) at Peptide or Subunit Levels: Ready for QC
Download
  • Resource Hub

Multi-Attribute Methods for Biopharmaceutical Analysis

Multi-Attribute Methods for Biopharmaceutical Analysis
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Related

Intact Protein Analysis
Protein molecular weight must be quickly confirmed, along with glycoform heterogeneity determination. Waters technologies deliver quick, accurate protein molecular weights for confirmation and determination of intact proteins.

Biosimilars
Regulatory agencies have provided paths for submitting applications for biosimilars. Waters offers analytical and informatics technologies to define the innovator product and to evaluate comparability against candidate biosimilars.

Glycan Profiling Solutions
Waters innovations have dramatically improved the quality, ease of use, and reduced sample prep and analysis times for glycan analysis. Waters offers complete workflow-based approaches for analyzing a glycoprotein across all structural levels.

Peptide Mapping
Achieve unmatched resolution of complicated protein digests, exceptional glycopeptide resolution, and shorter analysis times with UPLC separations and optimally selective and resolving peptide separation chemistries.

Learn more about Multiple Attribute Analyses.

Learn more about Multiple Attribute Analyses.
Expert perspectives on the adoption of LC-MS based attribute analysis for biopharmaceuticals
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