Alcura Obtains Manufacturing and Importation Authorization License, Expanding its Capabilities to Support Cell & Gene Therapy Developers
Alcura, a provider of specialized clinical trial services and a part of Cencora, has been granted a Manufacturing and Importation Authorization (MIA) license for cell and gene therapies (CGT) by the Spanish Agency of Medicines and Medical Devices. The certification, coupled with Alcura’s cryogenic storage capacity and team of experts, enables the company to provide enhanced support to developers planning to bring investigational or commercially approved CGTs into Europe.
Alcura can now import CGTs — or advanced therapy medicinal products (ATMPs) — manufactured outside the European Union (EU) via its facility in Viladecans, Spain. The batches are stored in temperature-controlled units while Alcura’s team of qualified persons conduct necessary reviews, including ensuring batches are manufactured in compliance with the clinical trial or marketing authorization and Good Manufacturing Practice (GMP) requirements. Once the batch is certified, Alcura will release the products for distribution across Europe.
“Managing ATMPs requires a deep understanding of the intricate regulatory requirements and specialized logistical support to ensure product quality and safety,” said Javier Casas,Vice President and Regional Director at Alliance Healthcare and Vice President of Clinical Trials. “We continue to expand our portfolio of solutions through strategic investments in infrastructure and innovative services, allowing us to offer more comprehensive support that can be tailored to our partners’ needs. With this MIA license, we can import and release ATMPs developed outside the EU, helping to facilitate efficient and secure access to quality products across Europe.”
There are nearly 2,000 clinical trials underway globally, according to the Alliance for Regenerative Medicine. In its 2024 State of the Industry Briefing, ARM forecasted a possible 17 CGT regulatory approvals across the United States and Europe this year.
Alcura offers a variety of logistics and regulatory services, including importation, batch certification, storage, packaging and labeling, export, and regulatory assessment. Alcura recently added liquid nitrogen tanks and additional temperature-controlled capabilities at its Viladecans facility, expanding its capacity to hold products that require storage at frozen or cryogenic (as low as -196 degrees Celsius) temperatures.
The new capabilities further expand the services available to CGT developers via Cencora’s network of businesses, including third-party logistics services, regulatory consulting, market access and reimbursement support, clinical trial and commercial distribution and patient services.
“The growing pipeline of cell and gene therapies offers tremendous promise for patients worldwide,” said Lung-I Cheng, Vice President and Head of Cell & Gene Therapy Service Line at Cencora. “Alcura’s MIA certification reflects the commitment across Cencora to continually elevate and expand our capabilities, enabling us to deliver integrated support across the product lifecycle to help our partners advance innovation and ensure they can reach the patients who need them.”
As part of its commitment to support CGT, Alcura is hosting a summit on September 19, 2024, “Overcoming Hurdles to Promote Advancements in Cell and Gene Therapies,” which will convene leaders across the industry to discuss the latest developments in the CGT sector and strategies to support the unique logistics and distribution requirements. For more information on Alcura’s capabilities or to register for the event, visit Alcura’s website.
About Cencora
Cencora is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We partner with pharmaceutical innovators across the value chain to facilitate and optimize market access to therapies. Care providers depend on us for the secure, reliable delivery of pharmaceuticals, healthcare products, and solutions. Our 46,000+ worldwide team members contribute to positive health outcomes through the power of our purpose: We are united in our responsibility to create healthier futures. Cencora is ranked #10 on the Fortune 500 and #24 on the Global Fortune 500 with more than $250 billion in annual revenue. Learn more at www.cencora.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240814175480/en/
Contacts
Mike Iorfino
610.545.9189
mike.iorfino@cencora.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
![](/data/images/public/58763726/70421602/511ee6c1-c38b-4856-a25b-f2fca9a47010-w_780.jpg)
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
Incyte and Syndax Announce U.S. FDA Approval of Niktimvo™ (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD)15.8.2024 00:34:00 EEST | Press release
Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™ (axatilimab-csfr), an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs.). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240814470216/en/ “With the approval of Niktimvo, patients with chronic GVHD whose disease has progressed after prior therapies, now have a new treatment option with a novel mechanism of action to help address the serious and devastating complications associated with this disease,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “Niktimvo is Incyte’s second approved treatment for chronic GVHD, underscoring our continued commitment to advancing the development of new medicines on behalf of patie
Uniphore Appoints Ravi Mayuram as New Chief Technology Officer14.8.2024 16:00:00 EEST | Press release
Uniphore, one of the world’s largest AI-native, enterprise-class companies, today announced the appointment of Ravi Mayuram as the company’s new Chief Technology Officer (CTO). Mayuram brings over 25 years of experience in engineering leadership and is poised to further Uniphore's leadership in Enterprise AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240814179209/en/ Ravi Mayuram, CTO of Uniphore. (Photo: Business Wire) At Uniphore, Mayuram will lead the engineering team and take on the scaling up of Uniphore’s engineering platform, technology and AI groups, while ensuring the highest standards of security and performance. Mayuram comes to Uniphore with a deep leadership background, having held several senior technical and management positions at leading software companies including Couchbase, BEA, HP, Informix, Oracle, and Siebel Systems. As an engineering leader, he has built teams from the ground up – in both establi
Hanshow Recognized as 2024 Sample Vendor in Gartner® Hype Cycle™ Reports for Retail Technologies and Wireless Technologies14.8.2024 16:00:00 EEST | Press release
Hanshow, a global leader in developing and manufacturing electronic shelf labels (ESLs) and digital store solutions, proudly announces its recognition as a Sample Vendor in the Gartner Hype Cycle for Retail Technologies, 2024, under the Smart Shelf category, as well as in the Gartner Hype Cycle for Wireless Technology, 2024, under the Bluetooth ESL category. The Gartner Hype Cycle reports evaluate the maturity and adoption of various retail technologies, providing valuable insights for retail CIOs to make informed investment decisions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240807460853/en/ Hanshow‘s Holistic Green Store Solutions (Graphic: Business Wire) According to the 2024 Hype Cycle for Retail Technologies report, “Smart shelves can provide critical real-time visibility to in-store, on-shelf availability; increase operational efficiency; guide customers and associates to discover products; and contribute inputs
Stockholm Fashion District Hosts Fashion Week Trade Where Swedish Initiatives Are Paving the Way for a Bright New Future14.8.2024 15:33:00 EEST | Press release
Stockholm Fashion District is revolutionizing the fashion industry by offering a vibrant platform for designers, creatives and buyers to connect. Unlike traditional trade platforms that occur just twice a year, Stockholm Fashion District hosts multiple trade shows annually - pushing the boundaries of industry conventions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240813925340/en/ Catwalk on the Grand Opening of Fashion Week Trade, 12-16 August 2024 (Photo: Business Wire) This innovative approach allows creatives in the industry to connect, inspire and gain valuable market exposure, all under the same roof. "The fashion industry is ever changing, therefore initiatives in trade conventions are crucial to reflect the current landscape and its eager pioneers" says Helena Walker, CEO Stockholm Fashion District During this Fashion Week Trade, 12-16 August, Stockholm Fashion District opens its doors to one of the biggest trade
Kape Technologies & ExpressVPN Announce Zac Eller as GM, Global Partnerships & Business Development14.8.2024 15:00:00 EEST | Press release
Kape Technologies and ExpressVPN today announce the appointment of Zac Eller as GM, Global Partnerships & Business Development, strengthening the group’s senior commercial team as they continue to expand their product offerings and services, building a safer, freer internet. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240814518374/en/ Zac Eller (Photo: Business Wire) The former Sony, Netflix, and Fox executive brings years of successfully scaling subscription-led growth businesses across the technology, media, and digital services sectors through strategic partnerships and new business channels. In his new role, Eller will lead the group’s global partnerships and business development initiatives for Kape’s privacy products, including its flagship privacy brand, ExpressVPN. Eller will be focused on building new partnerships and B2B channels to drive growth and awareness for Kape’s best-in-category digital apps and services
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