- Expansion meets the growing demand for small-scale commercial and clinical drug product manufacturing capacity
- Cytiva Aseptic Filling Workcells will be used in the manufacture of injectable drug products
PCI Pharma Services’ San Diego, California headquarters will install Cytiva Microcell Vial Filler and SA25 Aseptic Filling Workcell
March 8, 2022
PCI Pharma Services (PCI), a multinational pharmaceutical contract development and manufacturing organization (CDMO), has chosen Cytiva, a global life sciences leader, as its supplier of choice in expanding its drug product manufacturing capacity for small-scale commercial and clinical injectables. Cytiva Aseptic Filling Workcells reduce the risk of product contamination by using a completely closed and robotic aseptic process that can fill different dosage formats and can accommodate a wide range of molecules.
PCI will install a Microcell Vial Filler and an SA25 Aseptic Filling Workcell in San Diego, California, and a Microcell in Melbourne, Australia. Using the three aseptic filling machines, PCI will have the ability to fill monoclonal antibodies, peptides, oligonucleotides, mRNA and other modalities into vials, syringes and cartridges.
Cytiva Microcell Vial Filler
Olivier Loeillot, Vice President and General Manager, BioProcess, Cytiva, says: “PCI's expansion of its filling capacity shows the power a standardized, robotic filling platform can offer customers. They’ll appreciate the lower risk of the Workcells’ closed, robotic, and repeatable aseptic process. We look forward to collaborating with PCI to provide agile services for its clients — helping to deploy the right filling system for the job with shorter lead times."
Tim Roberts, Chief Commercial Officer, PCI Pharma Services, says: "Cytiva's leadership in robotic, aseptic fill-finish technology, deep scientific expertise, and world class solutions are a perfect fit with our global strategy: to be the bridge between life-changing therapies and patients around the world. Building on our recent acquisition of LSNE, utilizing the latest technology from Cytiva, allows us to be a single source for customers' fill-finish drug product needs, from clinical through commercial capabilities. When customers have a single source solution, it reduces supply chain complexity and accelerates speed to market. "
Cytiva SA25 Aseptic Filling Workcell
PCI’s capacity expansion will help bring more of the needed scale of aseptic filling capacity online at an important time for the industry. The number of global clinical trials increased 26% between 2017-2020, and a record 66 novel drugs were launched in 2020.i. Many drugs in development and early stages of commercialization are targeted, high-value medicines in oncology and rare diseases.
PCI’s new filling capacity is expected to be installed and validated at both sites by the end of 2022. They will become part of Cytiva’s aseptic filling user group, which has members on four continents and collaborates on issues such as system validation and usage.
iIqvia. Global Trends in R&D: Overview through 2020. URL: https://www.iqvia.com/insights/the-iqvia-institute/reports/global-trends-in-r-and-d Accessed: 17 December 2021.
About PCI Pharma Services
PCI is a leading global 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 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain) and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives. For more information, please visit pci.com
Cytiva is a global life sciences leader that works with academic and translational researchers, developers and manufacturers of biotherapeutics, cell and gene therapies, and new technologies such as mRNA, to enable the delivery of transformative medicines. Cytiva is a trusted expert with nearly 10 000 associates in more than 40 countries dedicated to customers’ speed, flexibility, capacity and efficiency in drug discovery, research, and manufacturing.
Ty Guzman-Touchberry, WE Communications, representing PCI Pharma Services
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