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- PCI Pharma Services announced infrastructure investments exceeding $1 billion to expand sterile fill-finish and drug-device combination capabilities across US operations. - The company is investing $100 million in a high-speed isolator filling line at its San Diego campus, scheduled to be operational in the first half of 2028. - New facilities will significantly increase capacity, including 250 million autoinjector units per year and production capabilities for 33 million vials annually. - The expansion includes Development Centers of Excellence in Bedford, NH and León, Spain, focusing on advanced drug delivery technologies and biologic modalities.
- PCI Pharma Services, a global CDMO specializing in biotherapies, received strategic investment co-led by Bain Capital and existing investor Kohlberg, with support from Mubadala Investment Company. - The Philadelphia-based company has achieved over 450 successful product launches in the past five years and provides integrated end-to-end drug development and manufacturing services. - Investment will fund organic and inorganic growth initiatives, including expansion of sterile fill-finish capabilities for injectables and high-potency specialized manufacturing capacity. - The strategic funding aims to strengthen US pharmaceutical manufacturing infrastructure while enabling faster market access for life-changing biopharmaceutical therapies.
- PCI Pharma Services is launching a new 50,000-square-foot sterile fill-finish facility in Bedford, NH, expected to reach full GMP production by summer 2025. - The facility features high-speed integrated fillers capable of producing up to 300,000 vials at speeds of 400 per minute, with twin 430-square-foot lyophilizers and fully isolated containment systems. - This marks PCI's third high-throughput sterile fill-finish facility built since 2021, enhancing capacity for late-phase clinical and commercial biologic drugs including monoclonal antibodies and fusion proteins. - The company is also establishing a Development Center of Excellence at the Bedford campus, expected to be operational by early 2026, handling both small molecules and biologics including antibody-drug conjugates.
- PCI Pharma Services is acquiring Ajinomoto Althea, a US-based sterile fill-finish CDMO, with the transaction expected to close in May 2025. - The acquisition provides PCI with its first North American manufacturing location for prefilled syringes and cartridges, plus high potent manufacturing capabilities for antibody-drug conjugates. - Althea's San Diego facilities will create a major manufacturing hub in Southern California's biopharma corridor, complementing PCI's existing clinical trial services in the region.
• Lyophilized drug approvals have seen a 15% average annual increase over the past decade, with 336 approvals between 2012-2022 representing 59% of all such approvals since 1954. • In 2022, the FDA approved 32 lyophilized drug products, with oncology and infectious disease treatments accounting for 82% of these approvals. • PCI Pharma Services is investing $100 million in expanding its lyophilization capabilities, including automated twin lyophilizers and an Annex 1 compliant isolator vial filling line in Bedford, New Hampshire.
