PA-PCI-PHARMA-SERVICES
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240821206732/en/
PCI becomes first drug product CDMO to navigate ICMRA multi-agency inspection process. (Photo: Business Wire)
The new ICMRA program is designed to abbreviate the time necessary to receive regulatory approvals from multiple countries. Regulatory agencies from several countries can convene for one inspection as a team, allowing CDMOs such as PCI to attain approval from each of the participating ICMRA countries simultaneously rather than undergo separate, phased inspections. For this pilot inspection, two agencies conducted the inspection – one onsite and the other virtually – while an additional five regulatory bodies observed virtually.
“We’re honored to have been selected as the first CDMO to participate in the ICMRA’s pilot program, allowing for agencies across the globe to conduct their regulatory approval process simultaneously,” said Tom McGrath, VP, Global Quality for Manufacturing & Development at PCI Pharma Services. “The program’s collaborative, comprehensive process increases the speed at which CDMOs or sponsoring pharma companies can begin manufacturing, packaging and ultimately commercializing life-changing therapies.”
PCI’s Bedford campus specializes in sterile fill-finish and lyophilization, two manufacturing processes commonly used with injectable and biologic therapies. PCI recently invested over $100 million in infrastructure enhancements at the site, building upon legacy disciplines toward its current destination: a multi-product, multi-capabilities campus servicing prominent pharma companies, across the drug product lifecycle from development to commercialization. Since PCI’s Bedford campus manufactures a broad array of drugs for both domestic and international markets, the site was an ideal candidate for the multi-agency inspection pilot program.
“At PCI, we are dedicated to bringing lifechanging therapies to patients as expediently as possible, and this welcome new program will further enhance our ability to do exactly that,” said Salim Haffar, CEO of PCI Pharma Services. “The ability to simultaneously gain approval from multiple, geographically diverse regulatory agencies is a game-changing, fast-tracking boost for the pharma industry, providing shorter paths to full-fledged sterile drug product production and commercialization, to the ultimate benefit of pharma companies and the patients they serve.”
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 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/20240821206732/en/
About Business Wire
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
ProAmpac Acquires International Paper’s Bag Converting Operations17.10.2025 16:09:00 CEST | Press release
ProAmpac, a global leader in flexible packaging and material science, has acquired the bag converting operations of International Paper (“IP”), a global leader in sustainable packaging. The acquisition expands ProAmpac’s converting capabilities, further advancing the company’s Fiberization of Packaging® strategy and enhancing its ability to deliver customized bag solutions for the grocery, convenience store, and quick-service restaurant markets. “Global demand for reliable, recyclable paper packaging continues to grow rapidly amid evolving consumer expectations and market trends redefining recyclability,” stated Greg Tucker, ProAmpac founder, vice chairman, and chief executive officer. “ProAmpac’s acquisition of IP’s bag operation supports our Fiberization of Packaging initiatives, helping us better serve customers by extending our expertise in material science to the US west coast with additional capabilities and redundancies,” continued Tucker. “IP’s bag business is strong, being bui
Pimicotinib Treatment Demonstrates Deep and Durable Tumor Responses and Continued Improvements in Pain and Function for Patients with TGCT17.10.2025 16:00:00 CEST | Press release
With median follow-up of 14.3 months, pimicotinib demonstrated increasing ORR over time, from 54% at Week 25 to 76.2%Global Phase 3 MANEUVER study demonstrated ongoing improvements in key secondary endpoints including pain and functionApplication for marketing authorization under review by China National Medical Products Administration (NMPA), with additional applications planned in the U.S. and other marketsNot intended for Canada-, UK- or US-based media Merck, a leading science and technology company, today announced the presentation of longer-term results from the global Phase 3 MANEUVER trial evaluating pimicotinib, an investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., for the treatment of patients with tenosynovial giant cell tumor (TGCT). This latest analysis showed that, with a median follow-up of 14.3 months, the objective response rate (ORR) for people treated with pimicotinib from the beginning of the stud
Vertex Announces Progress in Povetacicept Development Program and Presentation of New Data at American Society of Nephrology Kidney Week17.10.2025 15:04:00 CEST | Press release
- Food and Drug Administration grants rolling review of Biologics License Application for povetacicept in IgA nephropathy; Vertex to submit first module before end of year - - Second pivotal development program of povetacicept underway with Phase 2b/3 trial initiation in primary membranous nephropathy - - Updated data from RUBY-3 trial of povetacicept accepted for late breaking oral presentation; inaxaplin study design and APOL1-mediated kidney disease related data accepted for poster presentation - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced several important updates across its development program for povetacicept (pove), an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove has demonstrated best-in-class potential in IgA nephropathy (IgAN) and primary membranous nephropathy (pMN) and has pipeline-in-a-product potential across a range of B c
Qualcomm Announces Quarterly Cash Dividend17.10.2025 15:00:00 CEST | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.89 per common share, payable on December 18, 2025, to stockholders of record at the close of business on December 4, 2025. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensing
Illumynt Reports Q3 2025 Business Update17.10.2025 14:39:00 CEST | Press release
Q3 2025 was a busy quarter once again for us here at illumynt. In addition to naming a new CEO, we executed on a number of initiatives that are propelling our organization forward. Revenue for the quarter exceeded $30 million- keeping us on track for our 2025 plan. More importantly we executed three different large-scale data center decommission projects with almost no material ending up as scrap. All of the AI-focused enterprise equipment and components recovered from the decommissions were resold at top market value. We head into Q4 with high expectations and our eyes wide open. We’re celebrating the 20-year anniversary of our facility in Hong Kong and looking to add another location in the region to help us process inbound AI data center equipment. Stay tuned for updates. There will be more on the way. View source version on businesswire.com: https://www.businesswire.com/news/home/20251017446548/en/
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