Advancing ADC Development: End-to-End Solutions from Design to Characterization

Since the first FDA approval in 2000, the antibody-drug conjugate (ADC) pipeline has grown extensively with more than 100 ADCs in active clinical trials and many more in preclinical development.¹ In total, there have been 15 ADCs that have been FDA-approved across various cancer indications. Nine of the 15 ADCs that have been approved occurred after 2019, signaling a significant uptick in activity and interest in the development of commercialization.^1,2

And with good reason: ADCs are targeted cancer therapies that combine the specificity of monoclonal antibodies (mAbs) with the potency of small-molecule cytotoxic payloads. In addition to the mAb and payload, a covalent linker connects the two, providing multiple control mechanisms for payload release, including pH-labile and protease-sensitive linkers.

However, the inclusion of the payload-linker introduces additional complexity in preclinical development of ADCs and extensive optimization to balance safety and efficacy. The choice of bioconjugation strategy also affects the drug-to-antibody ratio (DAR), influencing (again) safety and efficacy. Furthermore, ADC characterization demands specific assays, such as internalization, to ensure thorough functional characterization.

Eurofins Discovery provides end-to-end ADC development services, offering chemical synthesis of payloads and diverse linkers within our OEB5-certified facility. We support a range of bioconjugation strategies, from stochastic to site-specific and glycan-based methods, followed by biochemical characterization (i.e., size exclusion chromatography (SEC), mass spectrometry for DAR analysis) and functional cell-based assays. Whether executing a complete ADC program or supporting discrete steps, Eurofins Discovery provides the technical expertise and flexibility to drive efficient, high-quality development.

Read our latest Case Study on ADC development at Eurofins Discovery.

References

1. Gogia P, Ashraf H, Bhasin S, Xu Y. Antibody–Drug Conjugates: A Review of Approved Drugs and Their Clinical Level of Evidence. Cancers. 2023;15(15):3886. doi:10.3390/cancers15153886
2. Liu K, Li M, Li Y, et al. A review of the clinical efficacy of FDA-approved antibody‒drug conjugates in human cancers. Mol Cancer. 2024;23(1):62. doi:10.1186/s12943-024-01963-7