PCI is a CDMO that provides integrated end-to-end sterile injectable drug development, manufacturing, combination product assembly, and advanced packaging solutions to increase product speed to market.
The company has launched more than 90 products each year over five decades of service. Spanning the cycle from development to commercialization, PCI offers injectable drug delivery solutions for large- and small-molecule therapies. Integrated sterile drug manufacturing, injectable assembly, testing, and packaging solutions optimize dosing for patients.
“Patient-centric solutions are profoundly reshaping the design and use of prefilled syringes in the pharmaceutical industry,” says Bill Welch, Executive Director Market Development at PCI. “As therapies become more specialized and the focus shifts toward enhancing the patient experience, prefilled syringes are increasingly prioritizing usability, safety, and convenience.”
For patients managing chronic conditions who require frequent injections, patient-centricity is critical and emphasizes ease of use, particularly for self-administration. He says that modern PFS designs now feature ergonomic grips, clearer labeling, and intuitive handling features, enabling patients and caregivers to administer treatments safely and confidently, outside clinical settings.
When it comes to sterile fill-finish, final assembly, testing, and packaging require rigorous attention to quality, precision, and regulatory compliance. CDMOs like PCI Pharma Services are investing in scalable final assembly and packaging technologies to ensure consistent, high-quality PFS production, including advanced aseptic prefilled syringe fill-finish capabilities and device testing systems.
PCI takes a collaborative approach when partnering with biopharma companies to ensure the success of their prefilled syringe programs. From engaging early during the sterile drug product development/manufacturing stage, facilitating proactive clinical discussions and guidance on device strategy, qualification and selection through to actual PFS introduction during clinical trials packaging design, scale-up, regulatory readiness, and commercial launch.
“Every stage of development is driven by a shared commitment to the patient,” says Mr. Welch. “We work closely with our partners to align drug delivery, aseptic filling, container closure selection, device functionality, human factors, labeling, testing, and packaging into a cohesive ecosystem – one designed to optimize usability, safety, and ultimately, therapeutic success. Device agnostic scalable technologies, complemented with an established range of PCI-owned tooling, allows our client partners to progress through clinical trials to commercialization with reduced investment and within an accelerated timeframe.”
This was originally published in Drug development & Delivery in May 2025
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