Robust analytical characterization is critical to the successful development of ADCs, from early screening to regulatory submissions. Due to their complex and heterogeneous nature, ADCs demand a specialized, multi-dimensional analytical strategy to evaluate purity, conjugation efficiency, drug-to-antibody ratio (DAR), aggregation, and stability. At Aurigene, we bring together cutting-edge instrumentation, methods, and a cross-functional scientific team to deliver a complete picture of your ADC molecule. Our analysis is not just about checking boxes. It's about generating actionable insights to guide your development decisions with confidence.
Drug-to-Antibody Ratio (DAR) Analysis
- UV-Vis Spectroscopy (UV280/λpayload)
- Hydrophobic Interaction Chromatography (HIC-HPLC)
- LC-Mass Spectrometry (LC-MS)
Quantifies average DAR and heterogeneity across the ADC population
Molecular Mass Analysis
- Intact Mass Analysis
- Reduced Mass Analysis
Confirms successful conjugation, C-terminal lysine clipping, and pyroglutamate formation
Aggregation & Purity
- Size Exclusion Chromatography (SEC)
Evaluates product purity, aggregation, and high-molecular-weight species
Conjugation Site Identification
- Peptide Mapping by LC-MS/MS
Determines exact sites of payload attachment and conjugation stoichiometry
Stability Studies
- Thermal Stability (DSF)
- Forced Degradation (pH, temp)
Predicts shelf-life and storage conditions of ADCs
Charge Variant & Isoform Analysis
- Capillary Isoelectric Focusing (cIEF)
- Ion Exchange Chromatography (IEX)
Endotoxin, Residual Solvent & Free Payload
- LAL Assay, GC, and HPLC-UV/LC-MS
Why choose Aurigene?
Aurigene stands out as a one-stop partner with deep analytical expertise tailored for ADCs. Our approach integrates bioconjugation chemistry, protein analytics, and mass spectrometry to deliver comprehensive characterization in a regulatory-ready format. With access to state-of-the-art instruments and advanced techniques, we don't just measure, we interpret. Our scientists provide meaningful analysis and recommendations that inform your decision-making across early development, formulation, and stability studies.
We offer:
Integrated analytics from early conjugation through IND
Customizable analysis panels based on ADC format and phase
Fast turnaround times with high-quality data packages
Flexible support for standard mAbs, bispecific ADCs, antibody-oligo conjugates, and more
With Aurigene, you gain more than data, you gain a scientific partner invested in the quality, safety, and success of your ADC program.
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We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
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