Cartridge Filling

Many injectable therapies are ultimately delivered through pen injectors and other drug delivery devices. Argonaut manufactures sterile cartridges for downstream device assembly and helps simplify the path from sterile fill-finish to the final combination product through coordination across multiple manufacturing partners.

Our team works closely with you to support cartridge component selection, manufacturing strategy, and downstream device integration. Through our strategic partner network, we can coordinate device assembly and related services to help reduce project complexity and streamline your commercialization timeline.

You can request integrated proposals covering both Argonaut’s services and those of our strategic partners. We also provide coordinated project management and aligned manufacturing timelines to reduce handoffs, minimize delays, and simplify communication.

Our strategic partner network provides access to:

• API manufacturing
• Pen injector and device assembly
• Labeling and secondary packaging
• Kitting
• Long-term GMP storage
• Distribution and logistics

Partnered Device Manufacturers:

Argonaut works with several device manufacturers to streamline manufacturing for both existing device platforms and custom solutions, including:

• SHL Medical – Maggie® 3.0 platform, Quanta®, and custom solutions
• Ensera – custom solutions

We also can work with your preferred manufacturer or service providers to offer an integrated solution.

Losing product during cartridge filling can delay studies, reduce available doses, and increase development costs. At Argonaut, every milliliter matters.

That is why we designed our cartridge 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 cartridge fill batch.

Argonaut’s equipment, manufacturing processes, and analytical strategy systematically reduce product loss while maintaining the highest standards of quality and sterility assurance.

Your drug product yield is maximized 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 improvements in yield and overall manufacturing efficiency, especially for high-value biologics and other complex sterile injectable products.

Cartridge filling is performed in a fully automated, isolator-based filling line designed to meet stringent EU Annex 1 expectations while minimizing operator intervention and contamination risk.

We manufacture under FDA 21 CFR Parts 210, 211, and 820 while supporting Annex 1, USP, EP, and JP requirements. Pre-Use Post-Sterilization Integrity Testing (PUPSIT) is available to support Annex 1 expectations for sterilizing-grade filters. PUPSIT verifies filter integrity after sterilization and before use, providing additional assurance that the filter has not been damaged during installation or sterilization. Argonaut has a dedicated, validated skid for its Aston filling line. 

Your team can rely on Argonaut’s experienced leadership and technical teams, who bring decades of aseptic manufacturing experience and a proven history of building and operating robust quality systems for commercial pharmaceutical manufacturing. We proactively identify manufacturing risks, develop practical solutions, and help sponsors navigate the evolving regulatory expectations for sterile injectable products.