In the current Pharma landscape, a lot can be asked of contract development and manufacturing organizations (CDMOs) by their partners – but what makes PCI such a good option for partnering?
PCI truly spans the cycle: connecting development and commercialisation, de-risking the supply chain by providing you with integrated end-to-end drug development, manufacturing and packaging solutions ultimately increasing speed-to-market and commercial success.
One of our key strengths is the flexibility we provide in offering solutions that cater to a diverse, global client base. Whether its niche personalised medicines or large-volume treatments, we have the capability and capacity to scale our services to meet your specific needs, delivering streamlined supply chain solutions including:
Drug development and manufacturing
We provide end-to-end clinical to commercial scale sterile fill-finish manufacturing, expertise in lyophilization, world-class potent drug product processing and global launch experience. We are experts and innovators offering full-service formulation development including in-house analytical development services for both sterile and non-sterile dosage forms. Our scalable solutions ensure a full service offering from the earliest stages of development through to commercial launch and beyond.
Clinical trial services
Committed to supporting clients at every stage of the clinical cycle, we deliver unmatched flexibility and a client-centric experience. Providing a seamless service, we support the global supply of investigational medicines with integrated pharmaceutical development, clinical drug product manufacturing for both injectable, oral and topical dosage forms, packaging, labelling, storage, distribution and full returns service. With temperature-controlled capabilities spanning controlled room temperature (CRT) to -196ºC, our clinical trial services are tailored to the unique needs of every project.
Advanced drug delivery and drug device combination products
At PCI, we are experts in sterile fill-finish and lyophilisation development and manufacturing. In addition, we provide specialist scalable solutions for the final assembly, testing and packaging of patient-centric delivery systems including auto-injectors, pre-filled syringes, pens and on-body devices; delivering a truly integrated and world leading, end-to-end service for advanced drug delivery injectable dosage forms.
Commercial packaging technology
With true customer focus and flexibility, we support the unique requirements of each product type and global market supplied. Utilising state-of-the-art packaging technologies, we provide advanced primary, secondary and tertiary packaging solutions for a diverse portfolio of conventional dosage forms including oral solids, powders, liquids, creams, and gels, as well as specialist, advanced, patient-centric injectable and parenteral delivery forms including vials, cartridges, pre-filled syringes and auto-injectors.
PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the delivery of CDMO services. Leading technology and continued investment enable us to address global outsourcing development needs throughout the product life cycle.
Commercial Annex 1 compliant sterile fill-finish and lyophilisation expansion
Enhancing our established sterile fill-finish capabilities and capacities, PCI committed $100m to expand our sterile development and manufacturing campus of excellence in Bedford, NH, US, with a new multi-product, 50,000ft2 facility. Over the past two years, we have methodically executed the expansion, allowing us to grow our breadth of services, providing best-in-class late stage clinical and commercial scale fully isolated vial filling and lyophilisation solutions for new and existing clients.
The new facility will provide increased capacity featuring Annex 1 compliant technology, including an aseptic fill-finish line within a fully isolated containment system, complete with twin 40m2 lyophilisers with automatic loading and unloading systems. The filling line can process batch sizes up to 300,000 vials at a rate of 400 vials per minute, providing much-needed large-scale capacity for the filling of life-changing small molecules and biologics, including high-value APIs such as mAbs, oligonucleotides and peptide drug products.
Expansion of advanced drug delivery and drug device capabilities and capacities
Complementing the continued growth and investment across our sterile manufacturing network and part of our global investment plan to address growing client demand for innovative injectable packaging solutions and readily available scalable capacity, we are investing more than $365m in facilities and infrastructure supporting the clinical and commercial final assembly and packaging of advanced drug delivery systems, with an emphasis on drug device injectable formats.
Europe: Facility acquisition and footprint expansion – Ireland
A key highlight of our ongoing expansion initiative is the acquisition of a purpose-built pharmaceutical packaging facility in Dundalk, Ireland. The 90,000ft2 facility is set to begin operations in Q4 2024 and will offer commercial scale packaging for both injectable and oral solid dose drugs. The site will also feature 3,000 pallet spaces of dedicated controlled ambient storage and 2,500 pallet spaces of 2-8°C refrigerated storage capacity to support its operations.
In addition, PCI has commenced construction on a new 80,000ft2 packaging facility at its CityNorth campus in Dublin, Ireland. Expected to be operational by Q3 2025, this plant will expand capacity for the final assembly, labelling and packaging of injectable drug products, including vials, pre-filled syringes and drug-device combination products including auto-injectors. The facility will also add 500 2-8°C pallet spaces for enhanced cold storage capacity, supported by an additional 4,000 ambient pallet space storage capabilities.
We are committed to supporting clients at every stage of the manufacturing cycle, delivering best-in-class services efficiently and effectively.
Find out more about our fully integrated CDMO Services.