Argonaut brings extensive experience filling high-value products, including N=1 personalized therapies, to every vial filling program. Our 100% isolator-based filling provides the highest level of separation and is designed to meet FDA and EU Annex 1 requirements, with capacity from clinical through commercial scale.

Scale Across Vial Filling Lines.

Our two fully automated, isolator-based filling lines support projects ranging from small clinical batches of just a few hundred vials to commercial campaigns exceeding a hundred thousand vials. 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.

LOKER LINE

ASTON LINE

Vial Size

2R – 30R

2R – 50R

Fill Speed

Up to ~2,000 vials/hr

Up to ~9,000 vials/hr

Fill Volume

0.25 to 30 mL

0.25 to 50 mL

Regulatory Phase

Clinical and commercial

Formulation Volume

Up to 200 L

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: Vial filling line specifications

Maximize Your Product Yield.

Every vial lost during filling is a dose that cannot be given to a patient. Lost product delays studies, reduces available doses, and adds cost at exactly the point in development where material is hardest to replace. At Argonaut, every milliliter matters.

That is why we design our processes to maximize yield. Our filling lines can reduce line loss to as little as 25 mL, helping preserve valuable drug product in every vial fill 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
Minimal to no glass-to-glass contact
Stability and analytical planning that minimizes vial consumption

These advantages deliver meaningful impact on yield and overall manufacturing efficiency, especially for high-value biologics, oligonucleotides, vaccines, ophthalmics, and other complex products.

Explore the science behind maximizing yield for high-value sterile injectable products. Download our free whitepaper

Advanced Vial Filling to Meet the Highest Regulatory Standards.

Vial filling is performed in automated, enclosed isolator lines that meet current regulatory expectations, including FDA and EU Annex 1 requirements. We also support PUPSIT on both our dedicated vial filling line (Loker) and multi-format filling lines (Aston).

Our team brings decades of aseptic manufacturing and quality experience to help sponsors manage risk and navigate evolving requirements for sterile injectable products.

Learn more about our regulatory compliance and quality systemsRegulatory Compliance

A Fill-Finish 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, process, and development timeline. Our experience with complex formulations, including LNPs, aseptic formulations, personalized medicines, and biologics, helps inform our strategy to account for formulation-specific processing requirements, product quality, and yield. Whether supporting an early proof-of-concept program, a first-in-human clinical study, or a commercial launch, you will get a practical, science-driven approach to your project.

Support from API Manufacturing to Final Distribution

Sterile fill-finish is just one step in manufacturing a sterile injectable product. You can simplify your overall manufacturing pipeline by engaging our strategic network partners for support, from API manufacturing to final distribution. Project management is simplified and you can request integrated proposals, assign a single project manager to oversee work across organizations, align manufacturing timelines to reduce handoffs, minimize delays, and streamline communication.

We can also work with your preferred manufacturer or service provider to provide an integrated solution.

Our strategic partner network provides access to:

API manufacturing
Device manufacturing and assembly
Labeling and secondary packaging
Kitting
Long-term GMP storage
Distribution and logistics

Explore Strategic Partners

We support every phase of your fill-finish program.

From your first clinical batch to full-scale commercial production, our vial filling lines are designed to support every phase of your program.

Argonaut Aseptic Vial Filling FAQs

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Do you offer lyophilization services for my pharmaceutical product?

No. We do not currently offer lyophilization services for injectable products.

Why should I choose an isolator-based filling line?

Isolators provide the highest level of sterility assurance and are the preferred aseptic processing technology of regulators worldwide, including the FDA and EU authorities.

What type of vials are available?

We fill Ready-to-Use (RTU) nested ISO vials ranging from 2R to 50R.

Do you fill in Ready-to-Use (RTU) vials?

Yes. Both filling lines support RTU vial processing.

Do you sterilize and fill into bulk glass vials?

No. We fill ready-to-use (RTU) vials.

Does Argonaut fill in isolators?

Yes. All filling is performed in isolators, providing the highest level of sterility assurance and contamination control.

How do you minimize product loss during filling?

We use precision pumping, 100% non-destructive weight checks, rescue dosing, and optimized manufacturing processes to reduce line losses to as little as 25 mL per batch.

What batch sizes can Argonaut support?

We support formulation volumes from approximately 200 mL to 800 liters.

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