{"entity":{"id":"high-potency-payload-synthesis","kind":"technology","name":"Payload-linker synthesis (high-potency API)","aka":[],"tldr":"Payload-linker synthesis makes the cytotoxic small molecules inside ADCs (exatecan, MMAE, DM1, PBD dimers), whose occupational exposure limits sit in the nanogram range, in facilities built so a speck of dust cannot harm a worker. A handful of licensed sites such as Lonza and WuXi STA supply them, and their lead times gate hundreds of ADCs in development.","summary":"Camptothecin derivatives (exatecan, DXd), auristatins (MMAE/MMAF), maytansinoids (DM1/DM4), and PBD dimers are synthesised under OEB 5/6 containment by specialists (Lonza, MilliporeSigma, WuXi STA, Piramal, Sterling, Ajinomoto Bio-Pharma, Levena, Cerbios, Kelun in-house) and sold as ready-to-conjugate linker-payloads. Supply is a gating factor for the hundreds of ADCs in development.","status":"established","asOf":"2026-09-08","links":[{"label":"21 CFR Part 211: current good manufacturing practice for finished pharmaceuticals","url":"https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211"}],"tags":["supporting"],"related":[],"cancers":[],"sections":["adcs","drug-discovery"],"technologies":["adc","topoisomerase-inhibitors","adc-cdmo-manufacturing"],"targets":[],"drugs":[],"companies":["lonza","wuxi-xdc","piramal-pharma-solutions"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"principle":"Multi-step synthesis and purification of cytotoxic small molecules and linkers under engineered containment, with occupational exposure limits in the nanogram range.","strengths":["Standardised, reusable linker-payload building blocks"],"limitations":["Few licensed sites","Long lead times","IP encumbrance on best payloads"]},"route":"/technologies/high-potency-payload-synthesis/","neighbours":{"section":[{"id":"adcs","kind":"section","name":"Antibody-Drug Conjugates","route":"/fronts/adcs/"},{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}],"technology":[{"id":"adc-cdmo-manufacturing","kind":"technology","name":"ADC bioconjugation manufacturing (CDMOs)","route":"/technologies/adc-cdmo-manufacturing/"},{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"small-molecule-api-synthesis","kind":"technology","name":"Small-molecule API synthesis","route":"/technologies/small-molecule-api-synthesis/"},{"id":"adc-supply-chain","kind":"technology","name":"The ADC supply chain (antibody, payload-linker, conjugation, fill)","route":"/technologies/adc-supply-chain/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"company":[{"id":"lonza","kind":"company","name":"Lonza","route":"/companies/lonza/"},{"id":"piramal-pharma-solutions","kind":"company","name":"Piramal Pharma Solutions","route":"/companies/piramal-pharma-solutions/"},{"id":"sterling-pharma-solutions","kind":"company","name":"Sterling Pharma Solutions","route":"/companies/sterling-pharma-solutions/"},{"id":"wuxi-xdc","kind":"company","name":"WuXi XDC","route":"/companies/wuxi-xdc/"}]}}