With over 25 years’ experience in lyophilization and sterile fill-finish manufacturing, PCI has developed industry leading technical expertise in the end-to-end processing of often challenging and complex processes.
Truly supporting full product lifecycle management from formulation and lyophilization cycle development through clinical to commercial sterile manufacturing, this high-volume lyophilization and liquid filling facility provides our clinical stage clients a seamless solution for scale-up as they prepare for commercialization.
In 2022 PCI announced a $100 million investment into expanding its sterile fill-finish service offering – can you provide an update on how this is progressing?
To enhance our sterile fill-finish capabilities and capacities we committed $100M to expand our sterile development and manufacturing campus of excellence in Bedford, NH with a new multi-product, 50,000 square foot facility. Over the past two years, we have meticulously planned and methodically executed the expansion, allowing us to grow our breadth of services as a global CDMO, providing best-in-class late stage clinical and commercial scale fully isolated vial filling and lyophilization 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 lyophilizers (40 square meters each) 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 (vpm) 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.
How does this new technology benefit your clients?
Our new large-scale vial filling, designed by groninger and SKAN is among the industry’s most versatile isolator lines. This innovative technology streamlines the filling process and ensures the highest level of sterility assurance for the final product. The enclosed system safeguards drug integrity and operator safety, employing the latest SKANFOG® decontamination technology which has been proven to effectively eliminate any potential microorganisms. The SKANFOG system uses an advanced micro-nebulization process to optimize particle size of the VHP droplets, this technology uses 80% less VHP than traditional vaporization systems.
To meet the growing product demand of some of the largest commercial requirements from our clients, this high speed line can fill 400 vpm, fulfilling batch sizes up to 300,000 vials. Additionally, the high-speed line’s smart fill technology minimizes product loss, ensuring no wastage of precious drug substance through features such as peristaltic pumps, defective vial identification prior to filling, re-stoppering, and under-fill correction.
While minimizing any loss of API or Bulk Drug Substance, inline camera inspection systems check each vial for stopper placement and drug product. Our overarching philosophy at PCI, is to constantly strive for perfection, delivering a quality and sterility assured drug product to patients, while meeting regulatory standards including the recently revised Annex 1.
When will the new site be operational, and what additional services will PCI offer?
The installation of the lyophilization, filling and isolator equipment is underway with engineering and validation runs scheduled to take place in the autumn. The site will be ready for GMP production in the first quarter of 2025. We are currently facilitating client visits to the site, and providing the opportunity to reserve capacity to help secure their future sterile supply chains.
This site, is our third high throughput isolator based commercial sterile fill-finish facility that we have built across our global network in the last three years. Our expert technical, engineering and project management teams alongside our long-term contractor partners are experienced in delivering complex, time sensitive capital projects, and we have a high-level of confidence in meeting the 2025 operational timeline.
What efforts does PCI undertake to build robust supply chains and mitigate risk?
Recent events underscore the necessity for secure and nimble supply chains. Biopharmaceutical companies require service providers that offer robust integrated solutions, supporting drug products from early phase development and clinical studies through to commercialization, mitigating the need to transfer between suppliers therefore reducing supply chain complexity and risk.
PCI ensures continuity of supply for life changing medicines by providing scalable sterile drug product development, manufacturing and lyophilization solutions from development to commercialization. Our integrated downstream custom assembly and packaging solutions for injectables, allows for ultimate knowledge sharing and communication between teams to ensure the drug product packaging is optimized for the product, patient and production. This integrated approach across global manufacturing and packaging teams not only streamlines supply chains but provides an accelerated delivery of life changing therapies to patients.
What investments has PCI made in packaging technology to support the growing injectable market demand?
Complementing the continued growth and investment across our sterile manufacturing network, we continue to expand our Centers of Excellence for the clinical and commercial packaging of patient-centric delivery systems across Europe, North America and the UK. These facilities are equipped with advanced drug delivery packaging technologies for the final assembly, labeling and packaging of vials, cartridges, prefilled syringes, advanced safety syringes, autoinjector and pen devices, along with in-line serialization. Combined with expanding global storage and distribution capabilities across a range of temperatures from controlled room temperature (15°C – 25°C), through 2-8°C, -20°C, -40°C, -80°C to -196°C, ensures a seamless solution.
Recently we announced an investment of $150M in a new 310,000 square foot final assembly and packaging facility at our Rockford, IL, site to meet the growing market need of specialized assembly and packaging for injectable drug-device combination products. Over 20 dedicated new suites will support the assembly and packaging of vials, prefilled syringes, autoinjectors, on-body injectors and pen-cartridges such as those for treating oncology, autoimmune diseases, diabetes and obesity. The investment also includes a 200,000 square foot warehouse for comprehensive storage solutions across various temperate ranges.
How does PCI Pharma Services differentiate itself from other CDMOs in the biologic market?
PCI spans the entire drug product lifecycle, connecting development and commercialization while de-risking supply chains to deliver true speed to market. Our expertise combined with innovative technologies means we deliver more than just a service, we are a trusted partner sharing an industry-leading depth and breadth of knowledge.
As part of the ongoing evolution of PCI we introduced speedsolutions™ to the market combining value-added services and expertise for an integrated approach to every client project. Speed-solutions such as packaging design and artwork or quality and regulatory services, de-risks and reduces the complexity of our client partners supply chain by eliminating the need to transfer services to alternative suppliers.
Differentiating what we do, PCI Pharma Services is commitment to and invests in digital transformation utilizing innovative technology. One such platform is pci | bridge™ which complements our project management capabilities by creating efficient and uncomplicated ways of working together.
This industry-leading digital customer platform provides our client partners with real-time insights into their portfolio of work at our sites around the globe, unlocking productivity with access to real-time supply chain information and digital workflows.
What can we expect in the future from PCI as an integrated solutions provider?
PCI remains committed to addressing dynamic market needs, whether in potent oral solid dose, sterile injectable process development, scale up, technology transfer, or custom packaging of specialized drug products. PCI are dedicated to fostering collaboration, creativity, and tailored solutions. Our purpose is that together, we bring life changing therapies to patients.
With over 50 years of experience, PCI is a respected provider of biopharmaceutical supply chain solutions worldwide. Our expertise enables us to deliver flexibility and excellence in all that we do. We will continue to invest in innovation, science, technology and digital transformation strategies to simplify processes and expedite drug product delivery to patients.
Central to our values and beliefs is our global commitment to environmental governance. Our ESG (Environmental, Social, and Governance) strategy, underscores our pledge to uphold environmentally sustainable practices, foster diversity and inclusivity, and positively impact our employees, partners, customers, patients, and communities in which we live and work. Our recently published inaugural Annual ESG Report outlines our achievements and ongoing commitment to set targets, aligning to the strategies of our customers as a trusted partner. We aim to act ethically, benefiting our employees, customers, communities, and the planet, while fulfilling a significant role in the pharmaceutical supply chain, enriching and extending lives.
Author
Jerome Detreille, Senior Director Business Development EMEA
After graduating from Strasbourg University of Pharmacy, France, Jerome spent 13 years as European Director of Business Development in Catalent for sterile injectables, before moving to Penn Pharmaceutical Services as Senior Director New Business Development in 2012. Here, he was part of the executive team who built the potent Contained Manufacturing Facility (CMF), which won the ISPE Facility of the Year award for Facility Integration (2014). In 2014, PCI acquired Penn Pharmaceutical Services, and Jerome continues to act as Senior Director of New Business Development to support the growth of PCI, especially in the development and manufacturing of OSD and sterile drug products.
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 Lyophilization Cycle Development Services.
Our dedicated team of specialists will be happy to discuss any of your Lyophilization Cycle Development needs. Contact us on +1 215-613-3600 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com