Alcura Obtains Manufacturing and Importation Authorization License, Expanding its Capabilities to Support Cell & Gene Therapy Developers

August 14, 2024 at 07:30 AM EDT

With the license, Alcura can offer import, storage and QP Batch Certification of investigational and commercial cell and gene therapy products

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.