Articles from PCI Pharma Services

PCI Pharma Services (“PCI”) – a world-leading integrated global contract development and manufacturing organization (CDMO) focused on innovative biologic and small molecule therapies – announced a series of major infrastructure investments that substantially deepen its sterile fill-finish and advanced drug delivery capabilities. As pharma manufacturers and their development partners increasingly prioritize US supply chain resilience, PCI’s latest investments come as part of a broader commitment exceeding $1 billion across the CDMO’s US and European operations, reinforcing its ability to provide seamless support for drug product development and manufacturing, clinical trial supply and drug-device combination assembly from clinical stages through commercial launch – all underpinned by global capacity, technical expertise, deep scientific knowledge, and an industry-leading quality and regulatory track record.

PCI Pharma Services (“PCI” or the “Company”), a world-leading global contract development and manufacturing organization (CDMO) focused on innovative biotherapies, today announced that it received a strategic investment co-led by Bain Capital and existing lead investor Kohlberg, and supported with significant reinvestment by Mubadala Investment Company (“Mubadala”). Partners Group will also continue to support the Company with a minority investment. Financial terms of the private transaction were not disclosed.

PCI Pharma Services (“PCI”) – a leading global contract development and manufacturing organization (CDMO) focused on innovative biopharma therapies – has completed its acquisition of Ajinomoto Althea, Inc. (“Althea”), a US-based sterile fill-finish CDMO and subsidiary of Japan-based Ajinomoto Co., Inc. For PCI, the acquisition is a cornerstone of a multi-year investment strategy spanning facilities in the United States and Europe. In the United States, Althea’s assets combine with PCI’s existing sterile fill-finish and advanced drug delivery operations to form a world-class, large-scale manufacturing hub in San Diego, complete with state-of-the-art large-scale aseptic facilities for prefilled syringes and cartridges. Among other categories, Althea’s campus specializes in customized, scalable oligonucleotides and peptides, supporting PCI’s existing manufacturing of complex formulations and lyophilization for a broad range of injectables – including nanoparticles, mRNA, MABs, proteins and other biologics.

PCI Pharma Services (“PCI”) – a leading global contract development and manufacturing organization (CDMO) focused on innovative biopharma therapies – is acquiring an entire equity stake in Ajinomoto Althea, Inc. (“Althea”), a US-based sterile fill-finish CDMO and 100% subsidiary of Japan-based Ajinomoto Co., Inc. Scheduled for completion in May 2025, the acquisition provides PCI with its first-ever North American manufacturing location for prefilled syringes and cartridges – including isolator technology for these formats – as well as high potent manufacturing suitable for antibody-drug conjugates (ADCs).

PCI Pharma Services, (“PCI”) a leading global contract development and manufacturing organization (CDMO) focused on biopharma’s most complex therapies, is investing more than $365 million in infrastructure supporting the clinical and commercial-scale final assembly and packaging of drug-device combination products utilizing advanced drug delivery systems, with an emphasis on injectable formats. Comprising new and expanded facilities in both Europe and North America, the effort is part of PCI’s global investment plan, is anchored and funded by recent new business, and is designed to augment and accommodate future growth.

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), has successfully completed the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection of its Bedford, New Hampshire campus. In doing so, PCI becomes the first drug product CDMO to navigate the multi-agency inspection process, a facet of the ICMRA’s new Collaborative Hybrid Inspection Pilot (CHIP) program, which is focused on the mutual assessment of facilities that manufacture therapies under the organization’s purview.

PCI Pharma Services, (“PCI”) a leading global contract development and manufacturing organization (CDMO), has released its first Environmental, Social & Governance (ESG) Report. A detailed overview of PCI’s multifaceted sustainability journey, the report showcases the strides taken from the program’s formal inception in 2021 through its 2023 fiscal year, and lays out ambitious goals for continued progress along multiple fronts.

Aldena Therapeutics, a private biotech company pioneering siRNA- based therapies for dermatological indications, has chosen PCI Pharma Services (PCI), a world-leading global contract development and manufacturing organization (CDMO) to formulate, package, and distribute ALD-102, an siRNA-based investigational injectable treatment for inflammatory dermatological conditions, all under one roof at PCI’s San Diego facility. ALD-102 is currently in preclinical trials and represents the most advanced therapy in Aldena's pipeline.

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), today announced that three new state-of-the-art automated sterile fill-finish machines at its San Diego and Melbourne facilities are now fully operational. The innovative machinery from Cytiva can be used to fill various sterile medications into vials and syringes for small-to-mid scale client needs. The equipment, paired with PCI’s end-to-end services, accelerates Speed to Study™, and drastically decreases the average turnaround time from proposal signing to the injectable product’s distribution.

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), today announced plans for a new 200,000-square-foot facility in Rockford, Illinois to enhance the organization’s capacity in injectable drug-device combination product assembly of both biologics and small molecules. Building on PCI’s leadership in this space with its Philadelphia Biotech Center of Excellence, the new facility is the second expansion building off the success in Philadelphia and will house over 20 dedicated customer suites with multiformat machines for the assembly and packaging of vials, pre-filled syringes, auto-injectors, and pen-cartridge combinations. This machinery can be used for the glucagon-like peptide 1 agonists (GLP-1) class of drugs prescribed to treat diabetes and obesity, as well as those needed for oncology treatment and autoimmune diseases.

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), today announced the opening of its Clinical Services Center of Excellence in Bridgewater, MA, the first facility of its kind to support the growing needs of global developers of biologics in the New England region. The new facility will provide increased flexibility and scalability for secondary packaging, distribution and cold chain storage of innovative therapies in development.

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), today announced a significant expansion of its world-class facility in Tredegar, Wales, UK, designed to help keep pace with the market growth of powerful, targeted oncology therapies.

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), today announced a major expansion of capabilities and capacity in aseptic liquid fill-finish and sterile lyophilization technology, an important manufacturing process commonly used with injectable and biologic therapies, with the investment of $100 million into the construction and enhancement of world-class facilities, at its Bedford, New Hampshire campus.

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), today announced the addition of three new exceptional automated sterile fill-finish machines in its San Diego and Melbourne facilities. Purchased from Cytiva, this remarkable equipment can pivot between filling different sterile medications into vials and syringes. The addition of these machines comes after PCI’s recent acquisition of Lyophilization Services of New England, Inc. (LSNE), specialists in the manufacturing of complex injectables for biologics and small molecules, bringing even broader capabilities to PCI clients across the entire product lifecycle and allowing them to bring their life-changing therapies to market with increased speed and safety.

PCI Pharma Services (PCI), a leading pharmaceutical and biopharmaceutical global integrated solutions provider, announced it has signed a definitive agreement to acquire Lyophilization Services of New England, Inc. (LSNE), a premier contract development and manufacturing organization (CDMO) headquartered in Bedford, New Hampshire, from global private equity firm Permira. Founded in 1997, LSNE has an impressive history of serving global pharmaceutical, biotechnology and medical device companies, differentiated by its high-quality cGMP aseptic fill-finish capabilities, and expertise in and ability to scale lyophilization, an important manufacturing process commonly used with injectable and biologic therapies. LSNE will expand PCI’s breadth of services as a global CDMO, building on PCI’s expertise in biologics packaging and specialty manufacturing. The acquisition adds five FDA-approved facilities in the U.S. (New Hampshire, Wisconsin) and Europe (Spain), with a sixth expecting approval over the coming months, and three additional facilities under development, to strengthen PCI’s global 30-site network.

PCI Pharma Services (PCI), a leading pharmaceutical and biopharmaceutical global outsourcing solutions provider, today announced that John Cullivan has joined the Company as a new member of the Executive Leadership Team in the role of Chief Corporate Development Officer. John will play a key role in PCI’s growth strategy and will accelerate its M&A, focusing on acquisitions to enhance PCI’s capabilities, enter new markets and geographies, and strengthen its portfolio of client solutions.