{"entity":{"id":"sterile-fill-finish","kind":"technology","name":"Sterile fill-finish and lyophilisation","aka":[],"tldr":"Sterile fill-finish is putting the finished drug into vials under sterile conditions. It is a frequent cause of shortages when capacity is tight.","summary":"Fill-finish capacity for biologics, ADCs, and radiopharmaceutical kits is concentrated (Catalent, Vetter, Baxter BioPharma Solutions, Thermo Fisher, Lonza, Samsung Biologics); lyophilisation is common for ADCs and mRNA products. Shortages of cisplatin and carboplatin in 2023 traced to a single sterile injectables plant (Intas/Accord) failing inspection, exposing the fragility of generic oncology supply.","status":"standard-of-care","asOf":"2026-09-08","links":[{"label":"FDA guidance: sterile drug products produced by aseptic processing","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice"}],"tags":["supporting"],"related":[],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"principle":"Fill-finish relies on aseptic filling in isolators, lyophilisation cycles tuned to product stability, and 100% container-closure integrity inspection.","strengths":["Established GMP"],"limitations":["Concentrated capacity","Generic injectable shortages","Long qualification times"]},"route":"/technologies/sterile-fill-finish/","neighbours":{"section":[{"id":"f-radiochemistry","kind":"section","name":"Radiochemistry & manufacturing","route":"/fronts/f-radiochemistry/"}],"technology":[{"id":"cold-kit-formulation","kind":"technology","name":"Cold kit formulation","route":"/technologies/cold-kit-formulation/"}],"term":[{"id":"hot-lab","kind":"term","name":"Hot lab (radiopharmacy dispensing area)","route":"/terms/hot-lab/"},{"id":"radiochemical-purity","kind":"term","name":"Radiochemical purity (RCP)","route":"/terms/radiochemical-purity/"},{"id":"radiolysis","kind":"term","name":"Radiolysis (self-radiolysis of radiopharmaceuticals)","route":"/terms/radiolysis/"},{"id":"radiopharmacy-term","kind":"term","name":"Radiopharmacy (practice and discipline)","route":"/terms/radiopharmacy-term/"}]}}