# ADC bioconjugation manufacturing (CDMOs)

Source: https://onco.cc/technologies/adc-cdmo-manufacturing/  
OnCo record `adc-cdmo-manufacturing` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

ADC bioconjugation manufacturing joins a payload so toxic it needs the top containment class (OEB 5) to an antibody, then checks drug-to-antibody ratio and free payload. Capacity sits with a handful of contractors such as Lonza, WuXi XDC and Samsung Biologics, so long queues and China-based exposure shape who can develop ADCs.

## Summary

ADC manufacturing needs high-potency containment (OEB 5), conjugation chemistry, and analytics for drug-to-antibody ratio and free payload. Capacity is concentrated in a handful of CDMOs: Lonza (Visp, incl. Synaffix technology), WuXi XDC, Samsung Biologics (new ADC plant 2025), Piramal Pharma Solutions, Abzena, Sterling, and Merck KGaA's MilliporeSigma. Payload-linker supply (MedChemExpress, Levena, Kelun's in-house) and lyophilised fill-finish are the other choke points.

## Fields

- Kind: Technology
- Status: established
- Last checked: 2026-09-08
- Tags: supporting
- Principle: Antibody produced by CHO cell culture; payload-linker synthesised under containment; site-specific or stochastic conjugation, purification, and DAR analytics; aseptic fill.
- Strengths: Specialised containment and analytics; Integrated antibody-to-vial programmes
- Limitations: Few qualified sites, long queues; Geopolitical exposure (China-based capacity); Payload-linker single sourcing

## Sources

- 21 CFR Part 211: current good manufacturing practice for finished pharmaceuticals: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211

## Connected records

- fronts: [Antibody-Drug Conjugates](https://onco.cc/fronts/adcs/)
- technologies: [Antibody manufacturing (CHO bioprocessing)](https://onco.cc/technologies/monoclonal-antibody-manufacturing/), [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Downstream purification (Protein A capture, viral clearance, polishing)](https://onco.cc/technologies/downstream-purification-chromatography/), [Payload-linker synthesis (high-potency API)](https://onco.cc/technologies/high-potency-payload-synthesis/), [Site-specific conjugation & linker chemistry](https://onco.cc/technologies/site-specific-conjugation/), [The ADC supply chain (antibody, payload-linker, conjugation, fill)](https://onco.cc/technologies/adc-supply-chain/)
- companies: [Abzena](https://onco.cc/companies/abzena/), [Lonza](https://onco.cc/companies/lonza/), [Piramal Pharma Solutions](https://onco.cc/companies/piramal-pharma-solutions/), [Samsung Biologics](https://onco.cc/companies/samsung-biologics/), [Sterling Pharma Solutions](https://onco.cc/companies/sterling-pharma-solutions/), [Synaffix (Lonza)](https://onco.cc/companies/synaffix/), [WuXi XDC](https://onco.cc/companies/wuxi-xdc/)
- terms: [BIOSECURE Act](https://onco.cc/terms/biosecure-act/), [CDMO (contract development and manufacturing organisation)](https://onco.cc/terms/cdmo/)

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