{"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":[],"cancers":[],"sections":["adcs","immunotherapy"],"technologies":["adc","cytotoxic-chemotherapy","generic-drug-shortage-response"],"targets":[],"drugs":[],"companies":["catalent","lonza","samsung-biologics","thermo-fisher"],"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":"adcs","kind":"section","name":"Antibody-Drug Conjugates","route":"/fronts/adcs/"},{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"}],"technology":[{"id":"monoclonal-antibody-manufacturing","kind":"technology","name":"Antibody manufacturing (CHO bioprocessing)","route":"/technologies/monoclonal-antibody-manufacturing/"},{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"biosimilar-manufacturing","kind":"technology","name":"Biosimilar manufacturing and comparability","route":"/technologies/biosimilar-manufacturing/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"downstream-purification-chromatography","kind":"technology","name":"Downstream purification (Protein A capture, viral clearance, polishing)","route":"/technologies/downstream-purification-chromatography/"},{"id":"generic-drug-shortage-response","kind":"technology","name":"Generic oncology drug supply and shortage mitigation","route":"/technologies/generic-drug-shortage-response/"},{"id":"sterile-injectable-generics-manufacturing","kind":"technology","name":"Generic sterile injectables (the 2023 platinum shortage)","route":"/technologies/sterile-injectable-generics-manufacturing/"},{"id":"mrna-lnp-manufacturing","kind":"technology","name":"mRNA and lipid nanoparticle manufacturing","route":"/technologies/mrna-lnp-manufacturing/"},{"id":"neoantigen-mrna-vaccine","kind":"technology","name":"Personalised neoantigen (mRNA) vaccines","route":"/technologies/neoantigen-mrna-vaccine/"},{"id":"adc-supply-chain","kind":"technology","name":"The ADC supply chain (antibody, payload-linker, conjugation, fill)","route":"/technologies/adc-supply-chain/"}],"company":[{"id":"catalent","kind":"company","name":"Catalent (Novo Holdings)","route":"/companies/catalent/"},{"id":"hikma","kind":"company","name":"Hikma Pharmaceuticals","route":"/companies/hikma/"},{"id":"lonza","kind":"company","name":"Lonza","route":"/companies/lonza/"},{"id":"samsung-biologics","kind":"company","name":"Samsung Biologics","route":"/companies/samsung-biologics/"},{"id":"thermo-fisher","kind":"company","name":"Thermo Fisher Scientific","route":"/companies/thermo-fisher/"}],"term":[{"id":"cdmo","kind":"term","name":"CDMO (contract development and manufacturing organisation)","route":"/terms/cdmo/"}]}}