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.
Workflow
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).
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Reduce charge heterogeneity analysis workflow from weeks to minutes
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Elucidate critical post-translational modifications (PTMs) including glycosylation, deamidation and linker modifications
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Enable mass identification of charge variants and modifications on intact ADCs
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Monitor charged modifications on ADC payload in near real-time
Intact ADC chacterization
Solution
- 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
Biologics Explorer software
Workflow
Drug antibody ratio monitoring
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.
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Complete solution for acquisition and tracking of DAR changes
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High-throughput DAR monitoring for large sample sets
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DAR quantitation and monitoring on compliance-ready software
Drug antibody ratio monitoring
Solutions
- Routine monitoring of DAR for ADCs
- Comprehensive assessment of DAR
ExionLC AE system
ZenoTOF 7600 system
Biologics Explorer software
- Routine monitoring of DAR for ADCs
- Comprehensive assessment of DAR
ExionLC AE system
ZenoTOF 7600 system
SCIEX OS software
ExionLC AE system
X500B QTOF system
SCIEX OS software
PA 800 Plus system
SDS-MW Protein Analysis kit for the PA 800 Plus system
Workflow
Characterization of ADC raw material
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.
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High-throughput assays for purity, charge heterogeneity and N-linked glycans
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Reduce method development time with parallel processing
Characterization of ADC raw material
Solution
BioPhase 8800 system
BioPhase CE-SDS Protein Analysis kit
Characterization of ADC raw material
Solution
BioPhase 8800 system
BioPhase Capillary Isoelectric Focusing (cIEF) kit
Characterization of ADC raw material
Solution
- High-throughput N-linked glycan analysis
- Rapid glycan expression profiling
BioPhase 8800 system
BioPhase Fast Glycan Labeling and Analysis kit
All resources
Ensure product quality and make ADC analysis accessible with a visually intuitive workflow for routine ADC characterization.
Gain accurate localization and detailed structural characterization with improved sensitivity for confident detection of fragments
Reduce charge heterogeneity analysis from weeks to minutes. Identify and monitor the charged modifications on ADC payloads in near real-time.
Gain high sequence coverage for proteins and identify critical modifications on a single platform solution
Streamlined LC-MS based workflows, with user-friendly data analysis software to enable attribute monitoring and informed decision making during process development.
Screen a large number of clones for lead clone selection with automation friendly mulit-capillary CE-SDS workflow.
Streamline evalutaion of multiple factors in a single set of experiments with a multifactorial DoE approach.
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.
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.
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).