Drug Device Combination Produces (DDCP)
Combination Product Manufacturing
Argonaut combines aseptic fill-finish expertise with partner device assembly, kitting, and packaging to help bring your drug device combination product (DDCP) to market.
Learn more about our combination product capabilities
Drug-device manufacturing is available through our trusted partners, including Ensera (pictured).
We support a range of combination products
Single-Entity Products
We can fill integrated drug-device products such as prefilled syringes, autoinjectors, wearable injectors, and connected delivery systems.
Co-Packaged Products
We also offer fill-finish of separate drug and device components that are then packaged together as a single kit for use by healthcare providers or patients.
Fill Finish Formats
Vials, prefilled syringes, cartridges
Types
Single entity, co-packaged
Assembly & Packaging
ISO 8 cleanrooms
Batch Sizes
10 units > 10K units
Formulation Volume
Up to 800L
Formulation Volume
Preclinical through commercial manufacturing
Regulatory
FDA and FDB licensed
ISO certified
In compliance with…
- EU Annex 1
- cGMP for Medical Devices (FDA QSR 21 CFR 820
- CBER/CDER
We support your combination product from fill-finish to final packaging.
Aseptic Fill-Finish
- Vials
- Prefilled syringes
- Cartridges
Analytical Testing
- In-process & Release testing
- Stability studies
- Container closure integrity testing (CCIT)
- Chemical compatibility assessments
Device Assembly & Packaging
- Safety device assembly*
- Autoinjector assembly*
- Combination product packaging
- Co-packaged products
*Partner offering
Regulatory Support
- Process validation
- PFMEA
- Pre-submission support
We only fill in isolators.
Argonaut operates two isolator-based, automated fill finish sites that are designed to reduce product loss to as little as 25ml per batch. Isolators delivers the highest sterility assurance levels and is preferred by regulators worldwide, including the FDA and EU.
Get pre-submission support for your product.
Our team supports your RFD process, including primary mode of action analysis, strategy, and documentation.
Image courtesy of Ensera.
Why Choose Argonaut for DDCP?
Combination products require expertise in both aseptic fill-finish and medical devices. Argonaut, together with partners like Ensera, supports development, manufacturing, and regulatory compliance for drug-device combination products.
Talk to our DDCP Team