Latest news with #PCIPharmaServices
AFP
02-05-2025
- Business
- AFP
Part of $1 Billion Investment Strategy, PCI Pharma Services Completes Acquisition of Ajinomoto Althea, Enhancing US Drug Product Manufacturing for Aseptic Filling of Prefilled Syringes & Cartridges
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. This press release features multimedia. View the full release here: PCI Pharma Services enhances US manufacturing of prefilled syringes & cartridges through acquisition of Ajinomoto Althea. Additional information regarding this acquisition is available at a dedicated webpage on PCI's website. The acquisition also adds high potent vial filling with lyophilization, expanding PCI's sterile fill-finish capacity and serving as an expedient entrée into the rapidly emerging oncology modality of high potent antibody-drug conjugates (ADCs). In fact, the move places PCI among the few US-based CDMOs capable of filling ADCs – a category the company initially began building toward earlier this year, with a sophisticated new pharmaceutical development lab for potent and non-potent compounds at its manufacturing Center of Excellence in Bedford, NH. The Bedford sterile fill-finish expansion strategy started with a large investment in a purpose-built facility featuring twin lyophilizers and a state-of-the-art large-scale isolator filling line compliant with Annex 1. That facility will be GMP ready this summer; since the plant's 2022 groundbreaking, PCI has methodically developed aseptic-by-design processes as part of its commitment to providing fully isolated high-volume vial filling and lyophilization solutions. Considering this, the acquisition is a natural next step in PCI's evolution in advanced drug delivery systems like prefilled syringes, cartridges and autoinjectors. Last year, PCI announced investments exceeding $365 million to support the clinical- and commercial-scale final assembly and packaging of drug-device combination products utilizing advanced delivery systems, with an emphasis on injectable formats. Comprising new and expanded infrastructure in both the United States and Europe, the effort bolsters PCI's ability to manage the full lifespan of DDCs, from sterile drug product development and manufacturing through clinical trial supply, product launch and commercialization. In the United States, the investment includes two new large-scale facilities at PCI's Rockford, Illinois campus. Building upon the company's successful Philadelphia Biotech Center of Excellence, the facilities will house over 25 dedicated suites with high-speed, multiformat lines for clinical- and commercial-scale assembly and packaging of prefilled syringes, autoinjectors, vials and pen-cartridge combinations, and incorporate extensive ISO-standard product testing capabilities and premium top-load cartoning technology. The campus also comprises capabilities for low- to medium-volume DDC assembly and packaging. Both facilities will be GMP ready in fall 2025. In Europe, PCI recently acquired a packaging and device assembly facility in Dundalk, Ireland, which provides commercial-scale operations for injectables and oral solid dose products. At its City North Dublin campus, PCI also expanded and constructed a 120,000-sq-ft packaging and device assembly services facility, which is slated to commence operations in summer 2025. Elsewhere in Europe, as part of an additional $25 million investment in its Leon, Spain facility, PCI is currently incorporating a sophisticated new high-speed filling line for syringes and cartridges. Equipped with isolator technology, the automated line delivers unsurpassed flexibility and reliability for biopharma customers. The effort also includes a recently completed state-of-the-art biologics development lab, further enhancing PCI's upstream capabilities. Assisted by the Althea acquisition, PCI's goal is to be among the first CDMOs to bring the whole lifespan of advanced drug delivery and drug-device combination products under one corporate roof – a journey spanning PCI's clinical trial supply network with cold chain storage solutions straight through launch and commercialization. 'Our pharma customers and the healthcare personnel and patients they serve are the heartbeat behind each stride we've made throughout this ambitious investment plan in sterile fill-finish and advanced drug delivery solutions,' said Salim Haffar, CEO of PCI Pharma Services. 'Concerning this latest step, Ajinomoto Althea enjoys a longstanding, well-earned reputation for producing novel biologics in various injectable formats. Welcoming Althea's talented professionals into the PCI family strengthens our commitment to turnkey customer partnerships and, ultimately, our dedication to helping improve patient outcomes through life-changing therapies.' About PCI Pharma Services PCI is a world-leading CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products' speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 35 sites across seven countries (United States, Canada, United Kingdom, Ireland, Germany, Spain and Australia), and over 8,000 employees working to bring life-changing therapies to patients. Leading technology and continued investment enable PCI Pharma Services to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and commercialization. Its clients utilize PCI as an extension of their business, and a collaborative partner with the shared goal of improving patients' lives. For more information, visit View source version on PCI Pharma Services Christopher Dale, Turchette Agency (973) 227-8080, ext. 116; cdale@ © Business Wire, Inc. Aviso legal : Este comunicado de imprensa não é um documento produzido pela AFP. A AFP não será responsável por este conteúdo. Para mais informações, por favor entre em contato com as pessoas ou entidades mencionadas no comunicado.
National Post
24-04-2025
- Business
- National Post
PCI Pharma Services to Acquire US-based Aseptic Fill-Finish CDMO Ajinomoto Althea
Article content Acquisition creates a world-class large-scale manufacturing hub in San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high potent formulations such as ADCs, complementing existing global sterile fill-finish and advanced drug delivery operations. Article content Article content PHILADELPHIA — 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). Article content Althea's robust clinical- and commercial-stage services for injectable drug products augments PCI's deep industry experience, aligning with the company's global sterile fill-finish capabilities and established expertise in advanced drug delivery. In addition, Althea's substantial knowledge base, skillsets and capacity in scalable, custom oligonucleotides and peptides complements PCI's existing manufacturing capabilities in complex formulations and lyophilization across a broad range of injectables – including nanoparticles, mRNA, MABs, proteins, and other biologics for delivery formats such as vials, bottles, prefilled syringes and autoinjectors. Article content The acquisition also adds high potent vial filling with lyophilization, making PCI one of very few US-based CDMOs capable of producing the emerging oncology modality of antibody-drug conjugates (ADCs). Building upon PCI's legacy in high potent molecules, the strategy creates an end-to-end offering for clients via specialized capabilities across the globe, and broadens its biologics development and manufacturing leadership. Article content For PCI's advanced drug delivery systems and drug-device combination business, Althea's assets supplement PCI's leadership position in final device assembly and packaging facilities in both Europe and North America. Acquiring Althea's San Diego campus also makes PCI one of the largest manufacturing centers in the US West Coast's biopharma stronghold and is a natural extension of PCI's current clinical trial services and early phase robotic sterile fill-finish capabilities, creating a scalable, flexible manufacturing complex with state-of-the-art facilities within minutes of each other. Article content 'To continue supporting the needs of our customers in their endeavors to bring life-changing therapies to patients, PCI continues to make sizable investments in the sterile fill-finish category that bring additional capabilities, capacity and technologies into our portfolio,' said Salim Haffar, CEO of PCI Pharma Services. 'Welcoming Althea into the PCI family expands our capabilities to support several therapeutic and drug delivery modalities, including the emerging ADC marketplace, and complements our broad end-to-end solutions alongside clinical trial services and advanced drug delivery.' Article content PCI is a world-leading CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products' speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain), and over 7,000 employees working to bring life-changing therapies to patients. Article content Article content Leading technology and continued investment enable PCI Pharma Services to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and commercialization. Its clients utilize PCI as an extension of their business, and a collaborative partner with the shared goal of improving patients' lives. For more information, visit Article content Article content Article content Article content Article content Article content
Business Wire
24-04-2025
- Business
- Business Wire
PCI Pharma Services to Acquire US-based Aseptic Fill-Finish CDMO Ajinomoto Althea
PHILADELPHIA--(BUSINESS WIRE)-- 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). Althea's robust clinical- and commercial-stage services for injectable drug products augments PCI's deep industry experience, aligning with the company's global sterile fill-finish capabilities and established expertise in advanced drug delivery. In addition, Althea's substantial knowledge base, skillsets and capacity in scalable, custom oligonucleotides and peptides complements PCI's existing manufacturing capabilities in complex formulations and lyophilization across a broad range of injectables – including nanoparticles, mRNA, MABs, proteins, and other biologics for delivery formats such as vials, bottles, prefilled syringes and autoinjectors. The acquisition also adds high potent vial filling with lyophilization, making PCI one of very few US-based CDMOs capable of producing the emerging oncology modality of antibody-drug conjugates (ADCs). Building upon PCI's legacy in high potent molecules, the strategy creates an end-to-end offering for clients via specialized capabilities across the globe, and broadens its biologics development and manufacturing leadership. For PCI's advanced drug delivery systems and drug-device combination business, Althea's assets supplement PCI's leadership position in final device assembly and packaging facilities in both Europe and North America. Acquiring Althea's San Diego campus also makes PCI one of the largest manufacturing centers in the US West Coast's biopharma stronghold and is a natural extension of PCI's current clinical trial services and early phase robotic sterile fill-finish capabilities, creating a scalable, flexible manufacturing complex with state-of-the-art facilities within minutes of each other. 'To continue supporting the needs of our customers in their endeavors to bring life-changing therapies to patients, PCI continues to make sizable investments in the sterile fill-finish category that bring additional capabilities, capacity and technologies into our portfolio,' said Salim Haffar, CEO of PCI Pharma Services. 'Welcoming Althea into the PCI family expands our capabilities to support several therapeutic and drug delivery modalities, including the emerging ADC marketplace, and complements our broad end-to-end solutions alongside clinical trial services and advanced drug delivery.' About PCI Pharma Services PCI is a world-leading CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products' speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain), and over 7,000 employees working to bring life-changing therapies to patients. Leading technology and continued investment enable PCI Pharma Services to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and commercialization. Its clients utilize PCI as an extension of their business, and a collaborative partner with the shared goal of improving patients' lives. For more information, visit
