CONSHOHOCKEN, PA — Alcura, a part of Cencora, has received a Manufacturing and Importation Authorization (MIA) license for cell and gene therapies (CGT) from the Spanish Agency of Medicines and Medical Devices. This certification, combined with Alcura’s cryogenic storage capacity and expert team, enables the company to support developers in bringing investigational or commercially approved CGTs into Europe.
Alcura will import CGTs—also known as advanced therapy medicinal products (ATMPs)—manufactured outside the European Union (EU) through its facility in Viladecans, Spain. The batches will be stored in temperature-controlled units while Alcura’s qualified personnel conduct necessary reviews, ensuring compliance with clinical trial or marketing authorization and Good Manufacturing Practice (GMP) requirements. Once certified, the products will be released 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 tailored to our partners’ needs. With this MIA license, we can import and release ATMPs developed outside the EU, facilitating efficient and secure access to quality products across Europe.”
According to the Alliance for Regenerative Medicine, nearly 2,000 clinical trials are currently underway globally. 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 various logistical and regulatory services, including importation, batch certification, storage, packaging and labeling, export, and regulatory assessment. The company has recently added liquid nitrogen tanks and additional temperature-controlled capabilities at its Viladecans facility, expanding its capacity to store products at frozen or cryogenic temperatures as low as -196 degrees Celsius.
“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 Cencora’s commitment 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.”
To further support the CGT sector, Alcura is hosting a summit on September 19, 2024, titled “Overcoming Hurdles to Promote Advancements in Cell and Gene Therapies.” This event will bring together industry leaders to discuss the latest developments and strategies to support the unique logistics and distribution requirements of CGTs.
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