# Sterile fill-finish and lyophilisation

Source: https://nuclide.cc/technologies/sterile-fill-finish/  
Nuclide record `sterile-fill-finish` (Technology). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.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: [Radiochemistry & manufacturing](https://nuclide.cc/fronts/f-radiochemistry/)
- technologies: [Cold kit formulation](https://nuclide.cc/technologies/cold-kit-formulation/)
- terms: [Hot lab (radiopharmacy dispensing area)](https://nuclide.cc/terms/hot-lab/), [Radiochemical purity (RCP)](https://nuclide.cc/terms/radiochemical-purity/), [Radiolysis (self-radiolysis of radiopharmaceuticals)](https://nuclide.cc/terms/radiolysis/), [Radiopharmacy (practice and discipline)](https://nuclide.cc/terms/radiopharmacy-term/)

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