# Sterile fill-finish and lyophilisation

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

## TL;DR

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.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-09-08
- Tags: supporting
- 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

## Sources

- FDA guidance: sterile drug products produced by aseptic processing: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice

## Connected records

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

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