ADC Analysis Support
Our analytical testing services support the entire antibody-drug conjugate (ADC) product development cycle from initial product characterization and method development/validation, all the way through cGMP clinical product release and stability evaluation. We have worked on many conjugate projects across multiple biologic drug-conjugate technologies for some of the leading ADC product developers, including:
- Antibody-Drug Conjugates
- Protein-Drug Conjugates
- Antibody-Peptide Drug Conjugates
- Peptide-Drug Conjugates
ADC analysis services and other conjugated product services include:
- Site Occupancy via Mass Spectrometry
- Experience with Key Conjugation (Linker) Technologies
- Analysis of Free Drug (Payload) and Naked Carrier Protein / Antibody
- Confirmation of Secondary Structure and Aggregation (HOS)
- Extensive Method Development and ICH Validation Capabilities
- Methods for Quantifying Drug-Conjugate Components for PK and PD Studies
- Mapping of PTMs, Disulfide Bonds and Glycosylation
- cGMP Lot Release and Stability Testing
- Reference Standard Characterization
- Solubility Studies, Pre-formulation and Formulation Development
- Forced Degradation Degradants, Impurities and Isoform Characterization
- Bridging Studies and Comparability Programs
Connect with a subject matter expert to learn more about how we can help support your programs.
eGuide: Bioanalysis from Early-Stage to Clinical Drug Development
Accounting for modality complexity, evolving regulatory expectations, and the critical importance of upfront planning, this eGuide explains how to identify risks early and align your bioanalytical strategy with the needs of your compound, your timeline, and your team.
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