A world-leading, integrated global contract development and manufacturing organization (CDMO) focused on innovative biologics and small molecule therapies, announced a series of significant infrastructure investments that will substantially enhance its capabilities in sterile filling and packaging, as well as advanced drug delivery. As pharmaceutical manufacturers and their development partners increasingly prioritize U.S. supply chain resilience, PCI’s latest investments are part of a broader commitment of over $1 billion to the CDMO’s U.S. and European sites. This will strengthen the company’s ability to provide seamless support for drug development and manufacturing, clinical trial delivery, and drug-medical device combinations—from clinical trials to market launch. All of this is underpinned by global capabilities, technical expertise, deep scientific knowledge, and an industry-leading track record in quality and regulatory compliance.
At the heart of PCI’s investment plan is a $100 million project at its San Diego site, the centerpiece of which is a high-speed isolator filling line for ready-to-use (RTU) prefilled syringes and cartridges. The line is scheduled to come online in the first half of 2028 and will more than double the site’s current syringe and cartridge filling capacity. It will be PCI’s second filling and packaging line in San Diego, which currently manufactures over 45 FDA-approved products. The site also has facilities for large-scale aseptic filling of prefilled syringes and cartridges, as well as specialized expertise in oligonucleotides, peptides, complex formulations, and freeze-drying for injectables such as nanoparticles, mRNA, monoclonal antibodies, proteins, and high-potency products.
Meanwhile, PCI’s Bedford, New Hampshire, site is commissioning a custom-designed, GMP-compliant isolator vial and freeze-drying facility. Once it enters serial production this month, the facility will be capable of producing batches of up to 300,000 vials at a rate of 400 units per minute, for an annual output of 33 million vials—one of the most powerful and advanced facilities of its kind in the U.S. The campus will also commission a custom-designed, high-efficiency sterile filling and packaging line, which is said to be unique in the U.S.
In both San Diego and Bedford, PCI has also invested in state-of-the-art automated visual inspection (AVI) systems for sterile filling and packaging applications. Overall, PCI’s US-based AVI infrastructure processes more than 70 million prefilled syringes and cartridges, as well as 40 million vials, annually, meeting the stringent requirements of global pharmaceutical manufacturers.
Investments in platforms for the assembly and packaging of drug-medical device combinations
In collaboration with leading equipment manufacturers, PCI has undertaken numerous infrastructure expansions for the production of autoinjectors and combination drugs/medical devices at its sites in Philadelphia, Pennsylvania, and Rockford, Illinois. These upgrades, which will be phased in over the next six months, will significantly increase both capacity and scale, thereby strengthening PCI’s integrated capabilities from clinical development to commercialization.
In 2027, PCI will expand its existing facilities with a third autoinjector production line, increasing its U.S. assembly capacity for autoinjectors and medical devices to over 250 million units per year. Thanks to multi-tool technology and flexible interchangeable components, the company’s autoinjector lines enable comprehensive rapid assembly, while a dedicated prefilled syringe (PFS) safety device line offers labeling and secondary packaging options.
In Philadelphia and Rockford, PCI’s US centers of excellence for packaging solutions are also located, boasting extensive capacity for solid oral dosage forms and injectable products, as well as substantial cold chain storage. The GMP-compliant facilities can be rapidly deployed to support clinical or commercial-scale programs. The available capacity of the two sites includes an annual production volume of 40 million blister packs, 70 million bottles, and 75 million vials.
Competence centers for pharmaceutical development
As part of the expansion of its manufacturing platform, PCI is investing in dedicated Centers of Excellence (CoE) in Bedford, New Hampshire, and León, Spain. These centers will encompass development capabilities in freeze-drying, formulation, analytical support, drug-device combinations, long-acting injectables, and ophthalmic preparations. The centers will produce both high- and low-potency small-molecule and biologic drugs in vials, pre-filled syringes, and cartridges. The Bedford Development CoE is expected to commence operations in May of this year, with León following in June.
“The pharmaceutical industry is at a turning point: Manufacturers are seeking trusted U.S.-based partners who offer the scale, suitability, and proven track record of quality and compliance needed to support the development and commercialization of next-generation therapies,” said Salim Haffar, CEO of PCI Pharma Services. “Backed by more than $1 billion in global infrastructure investments and decades of operational experience, PCI’s multi-year initiative to strengthen our domestic manufacturing footprint enables us to meet the growing customer demand for innovative medicines and delivery solutions—with the unwavering goal of delivering life-changing therapies to patients.”
About PCI Pharma Services
PCI is a leading global CDMO, providing its clients with integrated end-to-end solutions for drug development, manufacturing, and packaging, thereby reducing time to market and increasing their chances of commercial success. PCI has extensive experience built on more than 90 successful product launches per year and over five decades of dedication to healthcare. The company currently has 38 locations in seven countries (USA, Canada, UK, Ireland, Germany, Spain, and Australia) and employs over 7,500 people working to bring life-changing therapies to patients.
Thanks to leading technology and continuous investment, PCI Pharma Services is able to meet the global demands of drug development across the entire product lifecycle – from manufacturing and the clinical trial supply chain to commercialization. PCI’s clients leverage the company as an extension of their business and as a collaborative partner with the shared goal of improving patients’ lives.
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