Drug Device Combination Products (DDCP)
Combination Product Manufacturing
Argonaut provides sterile fill-finish services for drug-device combination products (DDCPs), supported by an integrated network of trusted device manufacturing, assembly, and packaging partners.
Together, we bring complementary expertise, aligned quality systems, and deep regulatory experience to simplify programs ranging from prefilled syringes and cartridges to vial presentations intended for future device or co-packaged product integration. Our teams work as one to support autoinjectors, wearable injectors, co-packaged products, and other combination product programs from clinical development through commercialization.
Drug-device manufacturing is available through our trusted partners, including Ensera (pictured).
Manufacturing solutions for injectable combination products
We support both single-entity and co-packaged combination products, and we tailor our manufacturing strategy to your product’s development stage and commercialization goals.
Single-Entity Products
We fill sterile drug products into different container closure systems which are intended for integration into a delivery device, including:
- Prefilled syringes
- Autoinjectors
- Pen injectors
- Wearable injectors
- Connected delivery systems
Device assembly is coordinated through Argonaut’s strategic partner network.
Co-Packaged Products
We also provide fill-finish services to co-packaged combination products, in which two or more products are packaged together as a single therapeutic product. Through our partnerships, we offer kitting, labeling, and packaging to deliver a market-ready combination product.
Clinical through commercial manufacturing
Whether you’re preparing your first clinical batch or launching a commercial combination product, our aseptic manufacturing capabilities scale alongside your program.
Fill-Finish Formats
Vials, prefilled syringes, cartridges
Product Types
Single-entity & co-packaged
Batch Sizes
100 to 100,000+ units
Regulatory Phase
Clinical and commercial
Formulation Volume
Up to 800 L
Manufacturing
100% isolator-based
End-to-end combination product manufacturing support
Manufacturing a combination product often involves several specialized organizations. Rather than managing each supplier independently, Argonaut helps coordinate your manufacturing program through our strategic partner network.
You can request integrated proposals that include both Argonaut’s services and those of our partners. We also provide coordinated project management to help align manufacturing schedules, reduce handoffs, simplify communication, and keep your program moving.
We can also integrate efficiently with your preferred device manufacturer or service providers when needed.
ARGONAUT SERVICES
Aseptic Fill-Finish
- Vials
- Prefilled syringes
- Cartridges
Supporting Services
- Analytical Testing
- Short-term Storage
PARTNER SERVICES
- Autoinjector assembly
- Safety device assembly
- Pen injector assembly
- Combination product packaging (off the shelf & custom design)
- Co-packaged kit assembly
- Secondary packaging & labeling
Partnered Device Manufacturers
Argonaut partners with SHL Medical and Ensera to streamline manufacturing for both existing device platforms and custom solutions.
Built for global regulatory compliance
Combination products require compliance with both pharmaceutical and medical device regulatory requirements. Argonaut’s quality systems, manufacturing infrastructure, and experienced technical teams are built to support the stringent requirements associated with sterile injectable combination products.
Our two fully automated, isolator-based fill-finish lines maximize sterility assurance while minimizing operator intervention and contamination risk. Performing fill-finish operations exclusively in isolators supports compliance with evolving global regulatory expectations, including EU Annex 1.
Argonaut is FDA-registered, California FDB-licensed, ISO certified, and manufactures under quality systems that support:
- EU Annex 1
- FDA cGMP for Medical Devices (21 CFR Part 820)
- FDA Center for Drug Evaluation and Research (CDER)
- FDA Center for Biologics Evaluation and Research (CBER)
From clinical development through commercial manufacturing, we help sponsors manufacture combination products with confidence while navigating the evolving regulatory landscape.
Why choose Argonaut for DDCP?
Manufacturing a combination product often means working with multiple partners for fill-finish, device assembly, and other specialized services.
Argonaut brings these pieces together. Our ISO certification enables us to support drug-device combination products (DDCPs), while our sterile fill-finish capabilities and network of trusted partners help you move your product from clinical development through commercial manufacturing.
Argonaut Combination Product FAQs
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