Whether supporting global clinical trials or commercial launches, PCI combines expertise, infrastructure and scalability to meet the growing demand for pre-filled syringes, and end-to-end scaled solutions from the largest global patient populations, down to batch sizes for the rarest of diseases
Few delivery formats have reshaped injectables as quickly as the pre-filled syringe (PFS). In both clinical trials and commercial supply, sponsors are pivoting to ready-to-use presentations for ease of administration, dose accuracy, conserving high-value drug product and patient convenience, especially as at-home self-injection becomes standard for many biologics and long-term therapies.
Driven by chronic disease prevalence, wider biologic and biosimilar therapy adoption, and the shift to user-friendly combination products, market analysts estimate double-digit growth for PFS through 2030, with the market projected to more than double from $8bn in 2024 to over $16bn by 2030.1
At PCI Pharma Services, we are proud to be at the forefront of this transformation. Our integrated services encompassing pharmaceutical development, sterile fill-finish (SFF), final device assembly, testing, labelling and global packaging deliver an end-to-end solution designed to accelerate speed to market while maintaining the highest standards of quality.
Why pre-filled syringes? Why PCI?
For clinical programmes, PFS eliminate preparation steps, reduce waste and improve dosing accuracy, simplifying trial execution and ensuring consistent patient outcomes. In commercial supply, these benefits translate into safer, easier administration, greater confidence and cost saving for patients and healthcare providers alike.
What sets PCI apart is our ability to seamlessly support the entire journey from early development through global commercialisation. Our clients gain more than manufacturing capacity, they gain a strategic partner who understands the unique requirements of PFS and drug-device combination (DDC) products, and who has strategically invested to deliver solutions at every stage.
PCI’s SFF: built for scale, designed for flexibility
PCI offers unrivalled experience in SFF of PFS, supporting clients from early-phase clinical supply through to global commercialisation. With a network of state-of-the-art isolator-based facilities across the US and Europe, PCI delivers scalable solutions for a broad range of molecules, including complex biologics, peptides and small molecules.
With true flexibility, our US facilities can scale from 2,000-200,000 syringes per batch, while our new fully automated isolator-based PFS line in León, Spain can deliver up to 12,000 units per hour, with a maximum batch size of 300,000 syringes. By combining world-class technical capabilities with true global reach, PCI offers a trusted pathway of scalable sterile syringe and cartridge filling supporting patient-centric DDC products, including needle safety devices, auto-injectors and on-body delivery systems.
Technical expertise from device strategy to packaging and label design
At PCI, we provide expert guidance across the full life cycle of DDC products. Our global specialists advise on device strategy, from leveraging established, lower-risk platforms with regulatory acceptance to evaluating novel delivery systems aligned to specific patient populations. Our in-house packaging design group applies human-factors engineering and technical functionality to create scalable, automatable, sustainable and regulatory-compliant solutions.
By engaging early in clinical phases and integrating cross-functional expertise in sterile manufacturing, engineering and operations, we ensure robust design-for-manufacture processes. This technical approach delivers optimised device and packaging solutions, mitigating risk, reducing cost, and supporting accelerated regulatory submissions and global commercialisation.
In-house testing for safe, global supply
With in-house laboratories, we provide a range of analytical testing, functional testing, and packaging performance testing services to support the development, clinical and commercial supply of medicines globally.
From product ID testing, method transfer, release and stability testing to drug-device combination product functional testing to International Organization for Standardization (ISO) standards, we ensure life-changing therapies meet regulatory guidelines and are ultimately safe for patient use.
Scalable clinical-to-commercial supply
Flexibility and customer focus define our drug-device assembly and packaging solutions. Our device-agnostic technologies operate from 3-300 parts per minute, with sophisticated inspections and force monitoring throughout, providing scalable solutions for a diverse range of platforms from early development through commercial launch. For clinical and low-volume supply, our specialised assembly lines offer a multi-platform solution, including PFS, needle safety device and auto-injector assembly, making them ideal for development studies, trials and niche orphan drugs. For later-stage programmes and commercial supply, our mid- to high-volume assembly technologies provide scalable, integrated solutions. Designed for efficiency, these lines can be quickly and cost-effectively retooled to accommodate new auto-injector formats. This adaptability ensures sponsors can respond to evolving technologies and future innovation while maintaining robust, reliable supply.
Strategic investments to meet global demand
Guided by client needs for flexibility, reliability and regional access, PCI continues to make strategic investments to expand our global SFF, device assembly, testing and packaging network, including:
- San Diego, US – acquisition of Ajinomoto Althea: with proven expertise in clinical and commercial sterile vial, PFS and cartridge filling, this strategic addition has expanded our capabilities, capacities and technologies, including isolator-based syringe filling lines, for the aseptic manufacturing of biologics, including mRNA, mAbs, LNPs, oligonucleotides, peptides and other complex modalities. This increased capacity can fulfil the needs for traditional PFS, PFS with advanced needle safety device technologies, as well as fulfilment of PFS for auto-injectors
- León, Spain – new PFS and cartridge isolator technology: strengthening our clinical to commercial scale PFS service solution in Europe is another important step, and as part of a $25m investment plan, we are investing in new high-speed isolator-based PFS and cartridge technology at our European sterile fill-finish facility in León, Spain. The new fully automated PFS filling technology can deliver up to 12,000 units per hour, with a maximum batch size of 300,000 syringes
- Ireland – expansion of DDC assembly and packaging: in 2024, PCI acquired a 90,000sqft pharmaceutical packaging facility in Dundalk, Ireland, providing commercial scale injectable drug device assembly and packaging together with ambient and refrigerated storage. Continuing the expansion, a new 80,000sqft facility at our CityNorth campus in Stamullen, Co. Meath is nearing completion. This facility will add further final assembly, labelling and packaging capacity for vials, PFS, and DDC products including auto-injectors and pen injectors
- Rockford, USA – clinical and commercial advanced drug delivery expansion: in the US, the investment includes two new large-scale facilities at our Rockford, Illinois campus. These state-of-the-art facilities will house over 25 dedicated suites with high-speed, multi-format lines for clinical and commercial-scale assembly and packaging of PFS, auto-injectors, vials and pen-cartridge combinations, and incorporates extensive ISO-standard product testing capabilities and premium top-load cartoning technology. The campus also comprises capabilities for low- to medium-volume DDC assembly and packaging complete with extensive cold chain storage capacity. Both facilities will be good manufacturing practice-ready in Autumn 2025.
These investments are guided by one principle: delivering flexible, future-ready solutions that empower our clients to meet patient needs today and tomorrow.
One integrated pathway
The future of drug delivery is patient-centric, convenient and ready-to-use. PFS are leading that future and PCI continues to build the infrastructure to make it possible.
As a fully integrated global contract development manufacturing organisation, we combine sterile manufacturing, packaging and supply chain expertise to deliver seamless solutions designed to simplify supply chains, reduce timelines and minimise risk. For sponsors, this means confidence that their programme can move smoothly from early phase clinical trials to global launch with a trusted partner invested in their success.
Standing at the forefront of evolution and as a trusted partner, we offer unparalleled expertise and solutions tailored to unique programme demands and patient needs. Our comprehensive approach and dedication to excellence in delivering a pristine customer service positions us as leaders in this rapidly growing industry.
Reference:
1. Visit: grandviewresearch.com/industry-analysis/pre-filledsyringes-market
We are committed to supporting clients at every stage of the manufacturing cycle, delivering best-in-class services efficiently and effectively.
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