Alcura
Alcura, a provider of specialised 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 authorisation 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 specialised 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.