Alcura, a prominent provider of specialized clinical trial services and a subsidiary of Cencora, has recently obtained a Manufacturing and Importation Authorization (MIA) license for cell and gene therapies (CGT) from the Spanish Agency of Medicines and Medical Devices. This significant achievement allows Alcura to offer import, storage, and Qualified Person (QP) Batch Certification services for investigational and commercial CGT products, positioning the company as a key player in the European market for advanced therapy medicinal products (ATMPs).
Enhanced Support for CGT Developers
The newly acquired MIA license empowers Alcura to import CGTs, including ATMPs manufactured outside the European Union (EU), through its state-of-the-art facility in Viladecans, Spain. Upon arrival, these batches are meticulously stored in temperature-controlled units while Alcura’s team of expert personnel conducts thorough reviews, ensuring compliance with clinical trial or marketing authorization requirements and Good Manufacturing Practice (GMP) standards. Once the batches are certified by the QP, Alcura can release the products for distribution across Europe, facilitating the efficient and secure access to high-quality CGTs for patients in need.
According to Javier Casas, Vice President and Regional Director at Alliance Healthcare and Vice President of Clinical Trials, “Managing ATMPs requires a deep understanding of the intricate regulatory requirements and specialized logistical support to ensure product quality and safety.” This sentiment underscores the critical role that Alcura plays in the CGT landscape, offering tailored solutions that cater to the unique needs of its partners. With the MIA license in hand, Alcura is well-equipped to streamline the importation and distribution processes for ATMPs developed outside the EU, contributing to the advancement of cutting-edge therapies throughout Europe.
Expanding Capabilities and Services
Recognizing the growing demand for CGTs and the complexities involved in their management, Alcura continues to invest in infrastructure and innovative services to enhance its offerings. In addition to importing and certifying ATMPs, Alcura provides a comprehensive range of logistics and regulatory services, including storage, packaging, labeling, export, and regulatory assessment. Recent enhancements at the Viladecans facility, such as the addition of liquid nitrogen tanks and expanded temperature-controlled capabilities, further underscore Alcura’s commitment to meeting the evolving needs of CGT developers and ensuring the integrity of their products throughout the supply chain.
Lung-I Cheng, Vice President and Head of Cell & Gene Therapy Service Line at Cencora, emphasized the significance of Alcura’s MIA certification within the broader context of the company’s commitment to supporting innovation in the CGT sector. Cheng stated, “The growing pipeline of cell and gene therapies offers tremendous promise for patients worldwide. 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 and drive advancements in the field.”
Industry Outlook and Collaboration
The landscape of cell and gene therapy is rapidly evolving, with nearly 2,000 clinical trials currently underway globally, as reported by the Alliance for Regenerative Medicine. In its 2024 State of the Industry Briefing, ARM projected a potential 17 regulatory approvals for CGTs in the United States and Europe this year alone, underscoring the growing momentum in the field. Alcura’s strategic investments in infrastructure and services position the company as a key player in facilitating the development and distribution of these innovative therapies, ultimately benefiting patients and healthcare providers across Europe and beyond.
As part of its commitment to fostering collaboration and knowledge sharing within the CGT community, Alcura will be hosting a summit on September 19, 2024, entitled “Overcoming Hurdles to Promote Advancements in Cell and Gene Therapies.” This event will bring together industry leaders to discuss the latest developments in the CGT sector and strategies to address the unique logistical and distribution challenges inherent in these therapies. By facilitating dialogue and collaboration among stakeholders, Alcura aims to drive innovation and accelerate the delivery of life-changing treatments to patients in need.
In conclusion, Alcura’s recent acquisition of the MIA license for manufacturing and importation marks a significant milestone in the company’s mission to support the development and distribution of advanced cell and gene therapies. Through its enhanced capabilities and tailored services, Alcura is well-positioned to meet the evolving needs of CGT developers and contribute to the advancement of innovative treatments across Europe and beyond. As the CGT landscape continues to expand, Alcura remains committed to driving progress and delivering integrated support to its partners, ultimately benefiting patients and healthcare systems worldwide.