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 By the end of 2025, 15 ADCs had received FDA approval across a range of cancer indications. As of August 2026, the new approval of Decnupaz^™ and Datroway^™ brought the cumulative total to 18. Most of these approvals have occurred since 2019, signaling a substantial increase in ADC development and commercialization.¹˒²

In addition, ADCs are expanding into new therapeutic targets, patient populations, treatment lines, and combination regimens. Important FDA developments in 2026 include:

Decnupaz^™ (pivekimab sunirine-pvzy; CD123): Approved as a new ADC for adults with blastic plasmacytoid dendritic cell neoplasm.
Datroway^™ (datopotamab deruxtecan-dlnk; TROP2): Expanded into first-line treatment for patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
Trodelvy^® (sacituzumab govitecan-hziy; TROP2): Moved into first-line treatment for advanced triple-negative breast cancer, both as monotherapy and in combination with pembrolizumab for defined patient populations.
Enhertu^® (fam-trastuzumab deruxtecan-nxki; HER2): Received two new indications in HER2-positive early-stage breast cancer, extending its use into neoadjuvant and adjuvant treatment settings.
Padcev^® (enfortumab vedotin-ejfv; Nectin-4): Approved with pembrolizumab as neoadjuvant treatment followed by adjuvant therapy after cystectomy for adults with muscle-invasive bladder cancer.

ADCs are targeted therapies that combine the specificity of monoclonal antibodies (mAbs) with the potency of small-molecule 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, efficacy, and stability. Furthermore, ADC characterization requires specific assays, such as internalization, to ensure thorough functional assessment. Site-specific conjugation, novel payload classes, bispecific constructs, and dual-payload ADCs are emerging, making these attributes even more important to control.

Eurofins Discovery provides end-to-end ADC development services, including chemical synthesis of payloads and diverse linkers within an OEB5-certified facility. We support a range of bioconjugation strategies, from stochastic conjugation to site-specific and glycan-based methods, followed by biochemical characterization using techniques such as size-exclusion chromatography and mass spectrometry for DAR analysis. Functional cell-based assays can then evaluate critical properties such as binding, internalization, cytotoxicity, and bystander activity.

Whether executing a complete ADC program or supporting discrete development steps, Eurofins Discovery provides the technical expertise and flexibility needed to evaluate increasingly sophisticated ADC designs and advance promising candidates efficiently.

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

References

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
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

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

References

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