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.
How to Choose ADC CDMO Companies
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.
Key Services Offered by Antibody-drug Conjugate Contract Manufacturers
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.
Advantages of Partnering with ADC CDMO Companies
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.
ADC CDMO Companies
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 range of services related to the development and GMP manufacturing of biotherapeutics, including monoclonal antibodies and recombinant protein-based products. [See CDMO profile]
- Shilpa Biologicals: CDMO supporting end-to-end biopharmaceutical development — from gene and cell line development through formulation, analytical development, process optimization, drug substance and product manufacturing, fill-finish and packaging. [See CDMO profile]
- Cultiply: Spanish CDMO that designs and optimizes production and purification processes for recombinant proteins, enzymes, DNA, and other biobased products, with expertise in process scale-up and bioprocess development. [See CDMO profile]
- SINOWAY INDUSTRIAL CO: One-stop CDMO offering comprehensive solutions for Antibodies (Abs), Antibody-Drug Conjugates (ADC & NDC), API and key intermediate manufacturing under strict GMP conditions. [See CDMO profile]
- CARBOGEN AMCIS: Expert in the development and cGMP manufacturing of Highly Potent Active Pharmaceutical Ingredients (HPAPIs), including Antibody-Drug Conjugates (ADC) and complex molecule synthesis. [See CDMO profile]
Related Information
Let MAI CDMO Help You Find the Right ADC CDMO Partner
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.
