PCI’s Advanced Drug Delivery
We understand the complexities of bringing drug-device combination products to market and accelerating patient-centric therapies from development to delivery.
Inspired by tomorrow
Horizons in our hands
From injectable therapies in prefilled syringes to autoinjectors and other advanced delivery systems, our expert teams provide end-to-end support across the full lifecycle, from clinical development through to commercialization, and beyond.
Powering drug-device journeys
Whether supporting global clinical trials or commercial launches, PCI combines expertise, infrastructure, and scalability to meet the growing demand for drug-device combination products with complete flexibility from the largest global patient populations, down to the smallest of batch sizes for rare diseases.
The only CDMO in the world providing the complete workflow to transform healthcare and patient's lives.
Sterile fill-finish
PCI offers unrivalled experience in sterile fill-finish (SFF) of prefilled syringes, cartridges and vials supporting clients from early-phase clinical supply through to global commercialization. With a network of state-of-the-art isolator-based facilities across North America and Europe, PCI delivers scalable solutions for a broad range of molecules, including complex biologics, peptides, and small molecules.
With true flexibility, PCI’s global SFF facilities can scale sterile syringe/cartridge production from 2,000 to 300,000 units per batch. Combining world-class technical expertise with global reach, PCI provides a trusted pathway for scalable syringe and cartridge filling, enabling patient-centric drug-device combination products including needle safety systems, autoinjectors, and on-body delivery devices.
Driven by innovation
Our patient-centric design and development expertise combined with device agnostic assembly, labeling and advanced packaging capabilities, offer flexible clinical and commercial solutions for a diverse portfolio of conventional and specialty injectable drug delivery devices.
Tailored to unique design, development and manufacturing needs, we offer a complete range of capabilities, services and expertise.
Designed to perform. Built to deliver.
An expert design process focused on human-factors engineering and technical functionality, optimizing packaging designs for manufacturability, scalability, automation, and sustainability.
End-to-end drug device combination services including:
- Prefilled syringe assembly
- Pen, autoinjector, and on-body injector final assembly
- Needle safety syringe assembly and precision labelling
- Integrated side or top-open cartoning
- In-process functional testing and final release
- Serialisation
- Cold chain storage
Delivering Patient-Centric Clinical to Commercial Excellence
US & EU Fill-Finish, 20+ DDC Final Assembly & Packaging Lines and 20K+ Cold Chain Pallets
Innovative solutions preserving drug product, accelerating timelines and controlling costs
Expert guidance from drug product development, container closure and device strategies, to regulatory submissions for product launch
Scalable support for clinical to commercial supply
Flexible final assembly and packaging of all advanced drug delivery formats
Streamlining supply chains with customized end to end integrated service offerings
Join us at our knowledge sharing seminar series, designed for biopharma companies developing injectable therapies considering the transition from vials to prefilled syringes (PFS) and ultimately to integrated drug–device combination (DDC) products.
Getting it Right Early
Strategic Investments to Meet Global Demand
Guided by delivering flexible, future-ready solutions that empower our clients to meet patient needs today and tomorrow, PCI continues to make strategic investments to expand our global sterile fill-finish, device assembly, testing and packaging network:
Expanding our capabilities, capacities and technologies in clinical and commercial isolator based sterile prefilled syringe and cartridge filling with the flexibility to support batch sizes from 2,000 to 200,000.
Two new facilities in Dundalk and at our City North campus in Ireland support commercial scale final assembly, labeling, and packaging for vials, prefilled syringes, and DDC products including autoinjectors and pen injectors together with extensive ambient and refrigerated storage.
Investing in new high-speed isolator-based PFS and cartridge technology at our European sterile fill-finish facility in León, Spain, delivering up to 12,000 units per hour, with a maximum batch size of 300,000 syringes.
Two new large-scale facilities at our Rockford, IL campus will house multi-format lines for clinical and commercial-scale assembly and packaging of prefilled syringes, autoinjectors, vials and pen-cartridge combinations, and incorporates extensive ISO-standard product testing capabilities and premium top-load cartoning technology.
Resources
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June 19, 2025
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March 17, 2025
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February 25, 2025
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February 24, 2025
Inspired by tomorrow, and with over 8000 people in 38 global GMP facilities, we support you from early-stage development through commercialization and beyond.