ADC analysis

Be clear on what you have and how much.

Understand ADC drug loading profiles regardless of the inherent heterogeneity and high molecular weight of these molecules. 

Overview

Up the game for ADC analysis

ADC analysis strategies tackle the characterization of the more structurally complex antibody drug conjugates (ADC) that are providing the next level of therapeutics to combat specific conditions.
These molecules have greater heterogeneity compared to unconjugated proteins and have a variable number of linkers and payloads. This enhances the number of proteoforms, making characterization more challenging.

Take control of the information with MS and CE based solutions designed to address the complexity of these next generation therapeutics with increased speed and detail.

Intact ADC characterization

Untangle the charge heterogeneity information of an intact ADC.

Charge heterogeneity is present in most biopharmaceutical protein products. For ADCs, the antibody, linker and payload all contribute to the heterogeneity, adding complexity to the charge variant profiles. 

An integrated icIEF-UV/MS workflow enables the simple determination of charge variant profiles while reducing resources and accelerating development timelines. Determine what is driving the change in the charge profile–the payload, the linker or the monoclonal antibody (mAb).  

  • Reduce charge heterogeneity analysis workflow from weeks to minutes
  • Elucidate critical post-translational modifications (PTMs) including glycosylation, deamidation and linker modifications
  • Enable mass identification of charge variants and modifications on intact ADCs
  • Monitor charged modifications on ADC payload in near real-time

Intact ADC characterization

Suited for:

  • Intact protein analysis of ADC molecules
  • Real-time monitoring of ADC payload modifications
  • In-depth characterization of PTMs on the ADC mAb
Intabio ZT system

Eliminate the guess work and monitor biologics at the intact-protein level, gaining insights into charge variant-associated quality attributes.

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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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Drug antibody ratio monitoring

Workflow

Take control of information on ADC quality. Drug antibody ratio (DAR) information is essential for assessing the quality of ADCs. Be clear on what you have. Understand ADC drug loading profiles with high throughput and intuitive LC/MS and CE solutions for DAR monitoring at the intact protein level.

  • Complete solution for acquisition and tracking of DAR changes
  • High-throughput DAR monitoring for large sample sets
  • DAR quantitation and monitoring on compliance-ready software

Comprehensive drug antibody ratio monitoring

Suited for:

  • Routine monitoring of DAR for ADCs
  • Comprehensive assessment of DAR
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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Routine drug antibody ratio monitoring

Suited for:

  • Routine monitoring of DAR for ADCs
  • Targeted assessment of DAR
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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SCIEX OS software

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

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CE solutions for DAR calculations

Suited for:

  • Calculating DAR ratios with CE
PA 800 Plus system

Characterize therapeutic molecules with confidence with the kit-based system.

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SDS-MW Protein Analysis kit for the PA 800 Plus system

Effective quantification and determination of protein purity and size.

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Characterization of ADC raw material

Workflow

Build on a strong backbone.
ADCs are complex molecules consisting of an antibody chemically tethered to a drug payload. While the complexity of the association is important to understand, the raw material itself is also fundamental to the success of the method of action and requires characterization. Accelerate ADC analysis with characterization of raw materials using high-throughput CE-based workflows.

  • High-throughput assays for purity, charge heterogeneity and N-linked glycans
  • Reduce method development time with parallel processing

Characterization of ADC raw material

Suited for:

  • High-throughput purity analysis
  • Rapid CE-SDS assay
BioPhase 8800 system

Purpose-built for the biopharmaceutical scientist for efficiency and quality, enabling multiple samples to be run in parallel.

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BioPhase CE-SDS Protein Analysis kit

Effective quantification and determination of protein purity and size.

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Characterization of ADC raw material

Suited for:

  • High-throughput charge heterogeneity analysis
  • Rapid cIEF assay
BioPhase 8800 system

Purpose-built for the biopharmaceutical scientist for efficiency and quality, enabling multiple samples to be run in parallel.

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BioPhase Capillary Isoelectric Focusing (cIEF) kit

Experimental protein isoelectric focusing point (pI) and analysis of charge variants.

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Characterization of ADC raw material

Suited for:

  • High-throughput N-linked glycan analysis
  • Rapid glycan expression profiling
BioPhase 8800 system

Purpose-built for the biopharmaceutical scientist for efficiency and quality, enabling multiple samples to be run in parallel.

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BioPhase Fast Glycan Labeling and Analysis kit

Release and label glycoprotein N-linked glycans for high-resolution capillary electrophoresis using laser-induced fluorescence (LIF) detection and an HR-NCHO separation matrix.

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Associated applications

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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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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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).

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