STERILE FILL-FINISH BUILT FOR CONFIDENCE AND CONTROL
When your program requires sterile manufacturing, precision, compliance, and reliability become non-negotiable. Our sterile fill-finish services are designed to support clinical supply with confidence, whether you are establishing a formulation for the first time or scaling processes for the long term.
We support a wide range of clinical needs through all phases of drug development. Our adaptable operations enable the flexibility to support a variety of container closure systems, keeping your program moving forward.
Our sterile fill-finish facilities are purpose-designed to meet current FDA, cGMP, and EU requirements for clinical manufacturing. Cleanroom environments are continuously monitored and controlled, and are supported by:
- Dedicated Water for Injection (WFI), purified water, and pure steam systems
- Clean compressed air system
- Inert gas overlay capabilities
- Back-up generator
- High resolution camera system for remote process monitoring
Sterile fill-finish services
Achieve efficient batch sizes, consistent yields, and accelerated release.
We support a range of batch sizes to conserve material while maintaining high quality and consistently strong yields. Embedded material-sparing strategies, combined with integrated QC, QA, and onsite project management, enable efficient testing, accelerated batch release, and smooth progression through clinical milestones. Our services support solutions and suspensions for injectable, ophthalmic, and otic products.
Our sterile fill-finish services include:
Automated Fill-Finish Manufacturing
Our isolated vial filling line enables state-of-the-art clinical supplies manufacturing with the highest level of sterility assurance and EU Annex 1 compliance.
- Glass vials – 2R, 6R, and 10R
- Nitrogen or argon inert gas overlay
- Filling, stoppering, and capping using pre-sterilized components (RTUs)
Manual Fill-Finish Manufacturing
Flexible systems that support clinical supplies with a wide variety of container closure systems. Our manual processing supports small runs up to 3,000 units.
- Glass vials
- Prefilled syringes
- Single and multidose ophthalmic dropper bottles
Fill-finish contract manufacturing: Trends, challenges, and the future
Sterile formulation and process support
We offer close alignment with formulation, process development, and packaging teams to ensure continuity from development through clinical supply.
- Batch sizes
- Packaging and labeling
Batch sizes
Manufacturing strategies designed to support material efficiency early and seamless scale-up as programs advance through clinical phases.
- Manual fill batches up to 3,000 units
- Automated fill batches up to 20,000 units
- Accommodating small batches from 500 mL to 100 L
Packaging and labeling
Our trusted clinical packaging, labeling, and kitting services provide a one stop shop for your clinical needs.
- Primary and secondary packaging: Vials, prefilled syringes, dropper bottles, boxes, and cartons
- Labeling: Open, blind/randomized, over labeling, multi-lingual, single panel, and booklets
- Kitting: standard kits, custom kit design, clinical trial patient kits, diagnostic kits, and ancillary item inclusion
