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Global Sterile Manufacturing and Lyophilization Capabilities of Large and Small Molecule Biologics – PCI Shows the Way

PCI’s global manufacturing capabilities are in complex formulations, high potency, and lyophilization and your capabilities cover a broad range of injectables including nanoparticles, mRNA, mAbs, proteins, oligonucleotides, and other biologics across multiple delivery formats.

Q: Can you please share any specifics about PCI’s sterile fill-finish achievements so far?

A: At the end of 2021, PCI Pharma Services acquired Lyophilization Services of New England, Inc. (LSNE), expanding PCI’s breadth of services as a global CDMO, building on our expertise in specialty drug product manufacturing and packaging at both clinical and commercial scale. Already perceived as a pioneer in the packaging of biologics, the addition of LSNE cements PCI’s reputation as a leading global CDMO, providing an integrated solution to clients across the entire drug product lifecycle from sterile development to commercialisation, meeting the demands of the ever-growing biologics market and bringing life-changing therapies to patients faster.

Our company culture, employees and processes are fully aligned to our strategy of focusing on our customers and the patients that they serve. Providing an all-encompassing streamlined sterile supply chain, many of our clients are leveraging the benefits of mitigating distribution and handling risks of their valuable biologic therapies as our sterile fill-finish manufacturing facilities are located within close proximity to our biotech packaging centres of excellence. Both of which, continue to grow with significant resource investments in terms of manufacturing and packaging processing technologies, in-house analytical laboratories and temperature-controlled storage and distribution capabilities.

Most recently, our sterile fill-finish and lyophilization facility in Madison, WI received its first commercial approval from the FDA. This now makes five commercially approved manufacturing facilities in our global network, with another four manufacturing sites coming online in the next year extending our global reach and capabilities further.

Q: How do you differentiate PCI Pharma Services from other CDMOs in the biologic market?

A: PCI continues to grow and evolve and as a fully integrated global CDMO, we are truly spanning the drug product lifecycle, connecting development and commercialisation, de-risking the supply chain and delivering true speed to market on behalf of our clients. We are a strategic partner and an integral part of the supply chain as the bridge between life-changing therapies and patients. 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 and by listening to our clients, we are proud to introduce speedsolutionsTM to the market. Providing the ultimate in solution flexibility and complete customer-centricity, speed-solutions combine value-added services and expertise, delivering an integrated approach to every client project, de-risking their supply chain by eliminating the need to transfer services such as packaging design and artwork to alternative suppliers as well as providing expert regulatory and clinical support services. Irrespective of where our clients enter the PCI world, they are supported with the option of an end-toend solution both within specific phases of the product’s lifecycle and across their development to commercialisation journey.