PCI Pharma Services Announces New Sterile Fill-Finish Capabilities Now Available in Melbourne and San Diego
18.4.2023 16:00:00 EEST | Business Wire | Press release
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230418005121/en/
The Microcell Vial Filler in action at PCI’s San Diego location. One of these machines is also located in PCI’s Melbourne facility. (Photo: Business Wire)
“As the capacity for CDMOs worldwide to take on new projects shrinks, we’re excited to be able to offer integrated sterile fill-finish capabilities, alongside our clinical packaging facilities, to new and existing clients in Melbourne and San Diego,” said Brad Payne, Chief Operating Officer, PCI Pharma Services. “Our increased capacity, stockpile of standardized components, including glass, and technical expertise means we can start running batches as soon as needed. This will cut down on the wait times many pharmaceutical companies are facing and begin to help alleviate the global capacity shortage for sterile drug product and downstream packaging.”
The Microcell Vial Filler and SA25 Aseptic Filling Workcell at PCI’s San Diego facility ensures the delivery of medicines from phase I through phase III, supporting local and global Clinical client needs. Additionally, a Microcell Vial Filler at Melbourne further enhances the early-stage services offered and brings additional capacity to Australia—the world’s leading phase I environment. These advanced machines expedite the filling process with automation and remove the need for human intervention in a sterile environment, creating compliance advantages over standard equipment.
“There are less barriers to entry to start a clinical trial in Australia, as well as significant cost benefits, and with Melbourne being an especially popular place to conduct phase I trials, we knew we needed to bring this capability and added capacity to the local market,” said Tim Roberts, Chief Commercial Officer, PCI Pharma Services. “In addition, we are then able to take our clients through their lifecycle journeys with the expansions and advanced capabilities in our New Hampshire and Madison campuses. With successful recent inspections at our Bedford facility by the Brazilian (ANVISA) and Japanese (PDMA) regulatory authorities, our global reach to supply life-changing therapies to patients quickly and safely is wider than before.”
To better support its clients throughout the world, PCI has also recently invested in expansions in Rockford, IL, and Tredegar, Wales, as well as established new facilities in Bedford, NH, and Bridgewater, MA.
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 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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230418005121/en/
Contact information
Ty Guzman-Touchberry, WE Communications
tgtouchberry@we-worldwide.com / +1-212-551-4877
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Galderma Receives U.S. FDA Approval for Differin ® Epiduo ® Acne Gel Prescription-to-OTC Switch22.5.2026 19:25:00 EEST | Press release
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260522074280/en/ The U.S. FDA approves Differin® Epiduo® Acne Gel Prescription-to-OTC switch This milestone represents yet another example of Galderma’s unique Integrated Dermatology strategy, demonstrating how proven innovations from its Therapeutic Dermatology portfolio can further strengthen its Dermatological Skincare offerings. The Prescription‑to‑OTC transition highlights Galderma’s scale and expertise in successfully commercializing dermatology innovations across the full spectrum of acne care. With the appro
Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with Thalassaemia22.5.2026 17:18:00 EEST | Press release
Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia, with an orphan medicinal product designation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260522186975/en/ Adam Plich, CEO and Co-Founder of Avanzanite Bioscience. “Thalassaemia is a complex, chronic and multisystem disease characterised by anaemia, ineffective erythropoiesis and haemo
ICE Brent and ICE WTI Perpetual Futures to Launch on OKX22.5.2026 15:30:00 EEST | Press release
OKX, a blockchain technology and trading company serving more than 120 million customers globally,and Intercontinental Exchange (NYSE: ICE), one of the world's leading providers of financial market technology and data powering global capital markets including the New York Stock Exchange, today announced plans for OKX to launch perpetual futures based on ICE's Brent Crude and WTI Crude energy benchmarks. The products are expected to be available to trade on OKX’s platform in jurisdictions where OKX is licensed to offer perpetual futures products. The new OKX contracts represent a major step forward in expanding regulated access to global commodity markets through digital asset infrastructure. This first product collaboration between OKX and ICE comes after the companies established a strategic relationship in March 2026. ICE operates some of the world’s leading exchanges, clearing houses and market data services across energy, commodities, fixed income and equities markets. ICE’s future
Enhertu ® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors22.5.2026 15:00:00 EEST | Press release
Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from patients with HER2 positive (IHC 3+) tumors in three phase 2 trials including DESTINY-PanTumor02,DESTINY-Lung01 andDESTINY-CRC02 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors. The recommendation will now be reviewed by the European Commission, which has the authority
Future Health Challenge Awards USD 300,000 to Early Detection and Population Health Sensing Tools on Sidelines of World Health Assembly22.5.2026 14:45:00 EEST | Press release
Three global teams developing early detection and real-time population health monitoring solutions have secured a total of USD 300,000 on the sidelines of the 79th World Health Assembly. The winning solutions address critical challenges in early detection, continuous population insight and more timely decision making, signalling a shift in health systems from late-stage treatment to earlier intervention. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260522587414/en/ Selected from 393 submissions across 68 countries, the winning teams were recognised through the inaugural ‘Future Health Challenge 2026: Building Anticipatory Health Systems through Population Sensing’, delivered by Future Health – A Global Initiative by Abu Dhabi in collaboration with MIT Solve. Health systems globally are facing rising costs and persistent delays in diagnosis, with many conditions still identified only after symptoms become severe. At the sam
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
