Syringe Filling
At Argonaut, we support prefilled syringe programs from clinical development through commercial manufacturing. Our fully automated, scalable, isolator-based capabilities provide the required precision, quality, and batch size flexibility, whether the syringe is intended for standalone use or device integration. We help simplify the path from development to market by aligning technical strategy, manufacturing scale, and regulatory readiness from the start.
Scale Your Syringe Filling Program.
Our Aston filling line is fully automated, isolator-based, and designed to support projects ranging from early clinical studies through commercial manufacturing. As your program needs change, our team works with you to scale manufacturing and maximize yield while maintaining process consistency, product quality, and regulatory compliance.
ASTON LINE
Syringe Formats
1 mL (standard and long), 2.25 mL, 3 mL, 5 mL
Fill Speed
Up to ~9,000 syringes/hr
Minimum Fill Volume
≥ 100 μL
Regulatory Phase
Clinical and commercial
Formulation Volume
Up to 800 L
Isolation Technology
Isolator-based
Pump
Peristaltic
Components Used
Ready-to-use (RTU)
Gas Overlay
Nitrogen
Weight Checks
100% in-process non-destructive
Table 1: Syringe filling specifications.
Navigating from a Vial to Prefilled Syringe
Many sterile injectable products begin in a vial before transitioning to a prefilled syringe as clinical development progresses or commercial strategies evolve. Because our Aston filling line supports both vial and syringe filling, your team can manufacture in the format that best fits your program today while reducing the complexity of transitioning to a different container closure system in the future.
When you’re ready, we help guide syringe component selection, process development, and the technical transfer from vial to prefilled syringe, all within the same manufacturing environment whenever possible. This approach helps minimize risk, avoid unnecessary technology transfers between organizations, and keep your program moving toward commercialization.
Maximize Your Product Yield.
Losing product during syringe filling can delay studies, reduce available doses, and increase development costs. At Argonaut, every milliliter matters.
That is why we designed our syringe filling processes to maximize yield. Our Aston filling line combines high-precision peristaltic filling, 100% non-destructive weight verification, and rescue dosing to minimize product loss while maintaining exceptional filling accuracy. Our Aston line can reduce line loss to as little as 100 mL when operating all four filling heads or 25 mL in single-head mode (excluding sterile filtration and PUPSIT), helping preserve valuable drug product in every batch.
We maximize your drug product yield through:
- Precise peristaltic filling
- 100% in-process, non-destructive weight verification
- Rescue dosing
- Low hold-up processing
- Non-destructive analytical testing
- Using high-quality components
- No glass-to-glass contact
- Stability and analytical planning that minimizes unit consumption
These advantages deliver meaningful impact on yield and overall manufacturing efficiency, especially for high-value biologics, oligonucleotides, vaccines, and other complex products.
Advanced Syringe Filling to Meet Global Regulatory Standards
Syringe filling is performed in a fully automated, isolator-based filling line designed to meet current regulatory expectations, including FDA and EU Annex 1 requirements. We also support PUPSIT on our Aston filling line.
Our team brings decades of aseptic manufacturing and quality experience to help sponsors manage risk and navigate evolving requirements for sterile injectable products.
A Syringe Filling Strategy Tailored to Your Program.
No two fill-finish programs are the same.
We help you develop a manufacturing strategy that reflects the unique needs of your formulation, syringe configuration, and development timeline. Our experience with complex formulations, including LNPs and biologics, helps inform strategies that account for formulation-specific processing requirements, product quality, and yield. Whether supporting an early clinical study, a commercial launch, or preparing for future combination product development, you will receive a practical, science-driven approach tailored to your project.
Support from API Manufacturing to Final Device Assembly
Sterile syringe filling is only one step in bringing a combination product or injectable therapy to market. Through our strategic partner network, we can simplify your manufacturing pipeline with integrated proposals and coordinated project management from API manufacturing through device assembly and final distribution.
Argonaut Syringe Filling FAQs
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