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Antibody-drug conjugates (ADCs) combine the targeting precision of monoclonal antibodies with the potency of cytotoxic drugs, making them one of the most promising therapeutic classes in oncology and beyond. Due to their complexity, working with specialized ADC CDMO companies is essential to navigate the technical, regulatory, and manufacturing challenges unique to these biologics.
From conjugation chemistry to payload handling, antibody-drug conjugate contract manufacturing requires expertise across biologics, small molecules, and high-potency containment — all within a tightly controlled GMP framework.
Selecting the right ADC CDMO means finding a partner that can manage the cross-disciplinary nature of these products. Key considerations include:
Experience with linker-payload technologies (e.g., cleavable/non-cleavable, MMAE, DM1)
Antibody modification expertise for site-specific or stochastic conjugation
HPAPI containment infrastructure for safe cytotoxic drug handling
Conjugation process development and scale-up capabilities
Integrated services covering biologics, small molecules, and analytics
Regulatory success with ADCs submitted under FDA, EMA, and PMDA
A reliable ADC CDMO can reduce time to clinic, ensure quality, and handle the complexity of your molecule under one roof.
Antibody-drug conjugate contract manufacturing typically includes:
Antibody production (monoclonal or bispecific) using CHO or HEK293 cells
Payload synthesis of cytotoxic small molecules
Linker and conjugation chemistry development
Conjugation under GMP, including DAR optimization and purification
Analytical characterization: DAR profiling, free drug analysis, stability testing
Formulation and aseptic fill-finish
CMC documentation and regulatory support
These services ensure full control of the ADC lifecycle, from preclinical to commercial.
Working with expert ADC CDMO companies provides multiple strategic and operational benefits:
Integrated biologics and HPAPI workflows for seamless ADC production
Specialized facilities with proper containment and handling protocols
Faster development through existing ADC platforms and linker-payload libraries
Regulatory preparedness with ADC-specific validation and data packages
Scalable processes to support clinical through commercial volumes
An experienced CDMO can help you manage risk, meet regulatory timelines, and ensure product quality at every step.
Some of the top ADC CDMO companies worldwide include:
53Biologics: CDMO specialized in decoding biologics production, from DNA to proteins, providing from preclinical to cGMP manufacturing. [See CDMO profile]
Mabion: Fully integrated CDMO offering a wide services associated with the development and GMP manufacturing of biotherapeutics, including monoclonal antibodies and any recombinant protein-based products. [See CDMO profile]
Shilpa Biologicals: CDMO which support Process Development, Gene to Cell Line Development to GMP to Formulation Development, Analytical Development, Process Development, Drug Substance, Drug Product, Fill-Finish and Packaging. [See CDMO profile]
NDC CDMO Companies | Nanobody-drug Conjugate Contract Manufacturing Services
Abs CDMO Companies | Antibodies Contract Manufacturing Services
mAb CDMO Companies | Monoclonal Antibodies Contract Manufacturing Services
Biologics CDMO Companies | Biopharmaceutical Contract Manufacturing
At MAI CDMO, we connect you with the most qualified ADC CDMO companies to match your product’s scientific and regulatory complexity. Whether you´re developing a new linker-payload system or scaling an approved conjugate, our network of antibody-drug conjugate contract manufacturing experts is ready to deliver.
Need a strategic manufacturing partner for your ADC? Contact us today and accelerate your next milestone.
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