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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Bangalore R and D Center
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
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.
Resources
FEBRUARY 25, 2025
Transforming Drug Discovery with Aurigene.AI
In the early 2000s, developing Sovaldi, a hepatitis C treatment, took over a decade and nearly $2 billion. Similarly, Zolgensma, a gene therapy for spinal muscular atrophy, required 15 years due to its complexity. However, the advent of artificial intelligence (AI) has revolutionized drug discovery. For example, in 2022, Pfizer's PAXLOVID, an oral COVID...
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Advancement in personalized medicine and how the CRDMO industry is part of the solution
Personalized medicine is transforming the healthcare landscape by customizing treatment plans to individual patients’ unique genetic, clinical and environmental characteristics. These are effective and less invasive treatments for a wide range of conditions. Contract Research, Development and Manufacturing Organizations (CRDMOs) play an important role...
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Cell Line Development
We enable development of stable and high yielding recombinant Mammalian and Microbial lines. ...
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Familiarization, process optimization, and cGMP manufacturing and supply of 30.0 kg of a Bioactive Nucleotide (NAD Booster)
Background: A US-based biopharmaceutical company approached Aurigene Pharmaceutical Services for the familiarization, process development, and cGMP manufacturing and supply of 30.0 kg Nucleotide product (NAD booster) for phase-appropriate studies. The synthesis of the desired product involves three linear stages, which starts with reaction of a pentose...
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Identification of Degradants of Thermal and Oxidation Stress Studies of Empagliflozin and Linagliptin Tablets by HPLC-PDA and LC-MS Instrumental Techniques
2022
Objective of the manuscript is to identify the degradants observed in the thermal and oxidation degradation sample of Empagliflozin and Linagliptin tablets by using LC-MS and HPLC-PDA instrumental techniques. Thermal and oxidation degradation samples were injected in HPLC-PDA and LC-MS instruments. Mass of the degradants were detected by LC-MS technique, ...
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Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2005
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...
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Wang-OSO3H catalyzed green synthesis of bioactive isoindolo[2,1- a ]quinazoline-5,11–dione derivatives: An unexpected observation
2005
The sulphonic acid-functionalized Wang resin (Wang-OSO3H) was explored as a polymeric and recov- erable acidic catalyst for the synthesis of isoindolo[2,1- a ]quinazoline-5,11–dione derivatives under green conditions. Thus the Wang-OSO3H ...
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Polycyclic Aromatic Compounds: A Simple and Efficient [(n-Bu3Sn)2MO4]n Catalyzed Synthesis of Quinazolinones and Dihydroquinazolinones
2005
A novel unprecedented approach for the synthesis of various quinazolinones and dihydroquinazolinones has been using [(n-Bu3Sn)2MO4]n as a catalyst. The reaction has been screened ...
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