PA-CENCORA
14.8.2024 13:31:31 CEST | Business Wire | Press release
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.
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/20240814175480/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
Global Beauty Market Grows 10% as AI and E-commerce Reshape Consumer Buying1.4.2026 03:00:00 CEST | Press release
Online sales outpace in-store by 6x as digital-first and AI-influenced commerce accelerates globally NielsenIQ (NYSE:NIQ), a global leader in consumer intelligence, today released its State of Beauty 2026 report, showing the global beauty market grew 10% year-on-year, with E-commerce expanding six times faster than in-store sales. The findings highlight a rapid shift to digital-first, AI-influenced commerce across key global markets. As consumer expectations evolve toward convenience, personalization, and seamless digital experiences, beauty brands are under increasing pressure to adapt. From AI-powered product discovery to social commerce and livestream shopping, the path to purchase is becoming more dynamic—requiring brands to move faster and engage consumers across an increasingly complex ecosystem. Key findings from the State of Beauty 2026 report: Global beauty sales grew 10% year-over-year, driven by strong digital acceleration E-commerce is growing 6x faster than in-store sales,
bet365 Partners with TestMu AI to Accelerate Global Release Velocity with Agentic AI Quality Engineering31.3.2026 19:01:00 CEST | Press release
Streamlines Hillside Technology testing across browsers and mobile devices while supporting rapid expansion into regulated markets. TestMu AI (Formerly LambdaTest), the world's first full-stack Agentic AI Quality Engineering platform, today announced that Hillside Technology Limited, the technology powerhouse behind global online gambling leader bet365, has adopted its platform to unify software testing and support hundreds of weekly production releases. The global online gaming industry is currently experiencing a massive shift, with the market projected to exceed $150 billion by 2030. As mobile gaming becomes the primary touchpoint for users, the technical complexity of delivering a seamless, low-latency experience has grown exponentially. For industry giants like bet365, the need to validate software across an infinite matrix of hardware, screen resolutions, and OS versions is a mission-critical requirement. This partnership ensures that, as gaming becomes more mobile-centric, bet36
IFF Secures First Heart Health Claim for Soy Protein in Australia and New Zealand31.3.2026 16:00:00 CEST | Press release
Regulatory milestone opens heart health growth opportunities for food and beverage manufacturers IFF (NYSE: IFF), a global leader in flavors, fragrances, food ingredients and health & biosciences announced today that a new heart health claim for isolated soy protein has been accepted by the Food Standards Australia New Zealand (FSANZ). The approval enables food and beverage manufacturers in Australia and New Zealand to link soy protein consumption with healthy blood cholesterol levels. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330523416/en/ First heart health claim approved for soy protein in Australia and New Zealand. “For decades, IFF has invested in the science behind soy protein and its role in supporting cardiovascular health,” said Tony Andrew, vice president of protein solutions for IFF Food Ingredients. “This approved claim validates years of rigorous research and collaboration. With our deep expertise in ing
Sub-Q Bionics Closes $1.5M Pre-Seed Round to Advance Next-Generation Solution for Lymphedema Care31.3.2026 15:26:00 CEST | Press release
Sub-Q Bionics, a medical device company developing next-generation solutions to improve care for patients living with lymphedema, today announced the successful close of its $1.5 million pre-seed funding round. The round includes investment from Mayo Clinic and Yeda, the technology transfer company of the Weizmann Institute of Science, as well as several private investors. The Israel Innovation Authority also provided matching funds. The funding will enable Sub-Q Bionics to continue to develop its novel bionic lymph node technology designed to transform how lymphedema is managed, based on scientific innovations from the Weizmann Institute and Shamir Medical Center. The system aims to provide a solution to manage fluid with a subcutaneous implant that will allow patients freedom of movement, automatic fluid management and reduction of symptoms such as pain and swelling. Lymphedema affects millions of patients worldwide, especially breast cancer survivors, and remains significantly under
HTEC Achieves SOC 2 Type II Attestation, Reinforcing Commitment to Client Trust31.3.2026 15:25:00 CEST | Press release
HTECtoday announced that it has successfully achieved a SOC 2 Type II attestation, audited by Deloitte, demonstrating the company’s commitment to maintaining high standards in security, availability, and confidentiality. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260331132225/en/ HTEC today announced that it has successfully achieved a SOC 2 Type II attestation, audited by Deloitte, demonstrating the company’s commitment to maintaining high standards in security, availability, and confidentiality. For clients, this means working with a technology partner whose practices are standardized, consistently executed, and independently verified over time. It reflects a level of operational maturity where security, reliability, and data protection are built into every engagement. Achieving this standard required coordinated effort across the entire organization. Compliance, engineering, delivery, security, IT, legal, and people t
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