# Antibody manufacturing (CHO bioprocessing)

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

## TL;DR

Antibody manufacturing means growing antibody drugs like pembrolizumab or trastuzumab in vats of engineered hamster cells, then purifying them. It is the industrial base for most modern cancer drugs.

## Summary

Chinese hamster ovary (CHO) cell lines in 2,000-20,000 L stainless or single-use bioreactors produce grams per litre of antibody, purified by Protein A chromatography and viral clearance steps. Capacity is held by pharma (Roche, Amgen, Lilly) and CDMOs (Samsung Biologics, Lonza, WuXi Biologics, Fujifilm Diosynth, Boehringer Ingelheim). Continuous processing, higher titres, and biosimilar competition are reducing cost of goods; ADC antibodies and bispecifics add engineering constraints.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-09-08
- Tags: supporting
- Principle: Stable transfected CHO clones expressing the antibody are grown in fed-batch or perfusion culture; downstream capture, polishing, viral inactivation and filtration, formulation and fill.
- Strengths: Mature, high-yield platform; Global capacity
- Limitations: Long tech-transfer timelines; Bispecifics and complex formats yield less; Capacity concentrated in few sites and countries

## 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/), [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- technologies: [ADC bioconjugation manufacturing (CDMOs)](https://onco.cc/technologies/adc-cdmo-manufacturing/), [Biosimilar manufacturing and comparability](https://onco.cc/technologies/biosimilar-manufacturing/), [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/), [Downstream purification (Protein A capture, viral clearance, polishing)](https://onco.cc/technologies/downstream-purification-chromatography/), [GMP, inspections, Form 483s and warning letters](https://onco.cc/technologies/pharmaceutical-gmp-inspections/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/), [Single-use bioprocessing systems](https://onco.cc/technologies/single-use-bioprocessing/), [Sterile fill-finish and lyophilisation](https://onco.cc/technologies/sterile-fill-finish/), [The ADC supply chain (antibody, payload-linker, conjugation, fill)](https://onco.cc/technologies/adc-supply-chain/)
- companies: [Boehringer Ingelheim BioXcellence](https://onco.cc/companies/boehringer-ingelheim-biox/), [FUJIFILM Diosynth Biotechnologies](https://onco.cc/companies/fujifilm-diosynth/), [Lonza](https://onco.cc/companies/lonza/), [Peregrine Pharmaceuticals (now Avid Bioservices)](https://onco.cc/companies/peregrine-avid/), [Samsung Bioepis](https://onco.cc/companies/samsung-bioepis/), [Samsung Biologics](https://onco.cc/companies/samsung-biologics/), [Sartorius](https://onco.cc/companies/sartorius/)

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