Therapeutic Area
Oncology CDMOs
Compare CDMOs with oncology manufacturing experience for cytotoxic compounds, antibody-drug conjugates (ADCs), and targeted therapies. Filter by containment level, modality, and scale.
386 companies listed
About Oncology Drug Manufacturing
Oncology is the largest therapeutic area by R&D spend, with over 2,000 drugs in clinical development globally. Manufacturing oncology products demands specialized capabilities: cytotoxic handling for traditional chemotherapy agents, high-potency containment for targeted small molecules, and bioconjugation expertise for the growing ADC (antibody-drug conjugate) pipeline.
Containment is non-negotiable. Most oncology APIs have occupational exposure limits (OELs) below 10 micrograms per cubic meter, requiring OEB4 or OEB5 engineering controls. This means dedicated facilities with isolators, continuous liner systems, split-butterfly valves, and validated cleaning procedures to prevent cross-contamination. Not every CDMO claiming "potent compound handling" can actually operate at OEB5 levels.
ADCs represent a unique manufacturing challenge. They combine biologics (monoclonal antibody production), small molecule chemistry (cytotoxic payload synthesis and linker chemistry), and bioconjugation (attaching payload to antibody). Few CDMOs can handle all three steps in-house. Most ADC sponsors work with 2-3 specialized CDMOs and manage the tech transfer between them.
Companies (386)
UPM Pharmaceuticals
United States
UPM Pharmaceuticals is a U.S.-based CDMO specializing in late-stage commercial manufacturing of semi-solid and oral solid dose products. Operating from a 475,000 sq ft cGMP FDA-registered facility in Bristol, Tennessee, UPM is a family-owned company with 30+ years of experience. They handle DEA-controlled substances and provide services from technology transfer and scale-up through commercial manufacturing. Capabilities include formulation development, analytical development, coated tablet manufacturing, pharmaceutical serialization, aggregation, and full packaging and warehousing.
Small Molecule Drug ProductOral Solid DoseFormulation Development
PeptiStar Inc.
Japan
PeptiStar is a Japan-based CDMO specializing in the development and cGMP manufacture of peptide and oligonucleotide APIs. From its 10,500 m² R&D and manufacturing site in Settsu, Osaka, the company supports programs from milligram-scale research material through clinical and commercial production. PeptiStar works with complex peptide structures, including long-chain, cyclic, branched and constrained peptides, non-natural amino acids and peptide conjugates. Its route-flexible manufacturing platform includes conventional and microwave-assisted SPPS, STag-PS and SYNCSOL liquid-phase technologies. Integrated downstream capabilities include preparative and continuous chromatography, membrane concentration and lyophilization, with 300 L filter reactors, chromatography columns up to 450 mm and lyophilizers up to 500 L. Purification and subsequent processing are conducted in Class 100,000 controlled areas. PeptiStar also develops and manufactures oligonucleotide APIs and peptide–oligonucleotide conjugates. The company was recognised by Exelixis as its 2025 CDMO of the Year.
Peptide APIOligonucleotide APIAPI Manufacturing
Frequently Asked Questions
What special capabilities do oncology CDMOs need?+
Oncology CDMOs need high-potency compound handling (OEB4/OEB5 containment with isolators and engineering controls), dedicated or segregated manufacturing suites to prevent cross-contamination, specialized waste handling for cytotoxic materials, worker safety programs including medical surveillance, and analytical methods validated for potent compound detection at very low levels. For ADCs, they additionally need bioconjugation suites and experience with linker-payload chemistry.
Why is containment critical for cancer drug manufacturing?+
Most oncology drugs are designed to kill rapidly dividing cells -- a property that makes them effective against tumors but hazardous to workers. Occupational exposure to cytotoxic compounds can cause skin irritation, reproductive harm, and potentially cancer. OEB4 and OEB5 containment (exposure limits below 1 microgram/m3) uses engineering controls -- isolators, airlocks, continuous liners, and HEPA-filtered exhaust -- to protect workers while maintaining product quality.
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