The Viladecans facilities of Alcura Health Spain, a company specializing in clinical trial logistics management and part of Cencora, an international group offering pharmaceutical services and solutions for human and animal health, have received the Manufacturer Import Authorization (MIA) granted by the Spanish Agency of Medicines and Medical Devices (AEMPS). This authorization allows them to import and release products related to gene, cell, and tissue engineering therapies, also known as ATMPs (Advanced Therapy Medicinal Products). This makes the Viladecans facilities in Barcelona the first center in Cencora's international network to obtain this authorization. 

The acquisition of this permit paves the way for bringing innovative therapies and precision medicine closer to patients. Contributing factors include Alcura's efforts to enhance its infrastructure by incorporating nitrogen tanks at -196ºC and strengthening its team with highly specialized professionals in advanced therapies. 

According to Josep Oriol Nicolás, Director of Strategic Development at Alcura Health Spain, “With this new authorization, we reinforce our position as a disruptive and innovative company in the clinical trial logistics market, with an increasingly global reach, focusing on offering comprehensive solutions tailored to the specific needs of any type of patient. This permit not only represents access to new commercial horizons but also an unwavering commitment to quality and safety at the forefront of medical research, crossing borders to offer health solutions that make a difference.” 

Expansion of Highly Specialized Storage Services 

The certification was obtained after passing a rigorous process involving a series of regulatory, quality, and product safety challenges and requirements, controlled manufacturing processes, and sustainability guarantees. In this sense, Alcura has enhanced its highly specialized storage capabilities at the Viladecans facilities with liquid nitrogen tanks for advanced therapy samples. 

With the new equipment, Alcura can store at -196˚C, ensuring the preservation of these products focused on gene, cell, and tissue therapy research. With the installation of this new equipment, the Viladecans clinical trial operations center can now cover the full range of temperatures required by both chemically or biologically synthesized products and advanced therapies. Until now, Alcura already had storage zones ranging from 2ºC to 8ºC, -20ºC, and -80ºC. From now on, the Viladecans facilities, which cover an area of 3,500 m², will have a wide range of storage areas prepared for the safe preservation of biological materials such as cells, tissues, and genetic material at the necessary temperature for each type of therapy. 

With the expansion of services, Alcura continues to strengthen Spain as a Clinical Trials Center of Excellence within the Cencora group, enhancing its capabilities to support the most advanced clinical trials, especially in advanced therapies, with a particular emphasis on products such as CAR-Ts, which have shown high levels of clinical success. 

Ruth Martin Ruíz, Clinical & Health Services Director in Spain, stated, “This expansion represents another step in our commitment to transforming Alcura into a leading hub for innovative and patient-focused clinical trials, as part of our strategy to build a solid market presence.” 

Safety and Accessibility 

Alcura has opted for liquid nitrogen storage equipment that facilitates sample accessibility. These units feature electronic controllers that continuously monitor the temperature and have a comprehensive alarm system to ensure total sample security. 

The logistics management and storage of advanced therapy products are subject to strict safety protocols and guidelines to prevent cross-contamination during handling and storage, ensuring their quality and efficacy. Thus, the facilities are made available to the entire pharmaceutical industry, particularly serving research as Alcura expands its capacity to approach new client profiles and increase the volume of operations. 

In 2022, Alcura Health Spain developed a total of 823 clinical trials of various types, including clinical phases I-III and post-commercialization. The number of trials the company participated in 2022 is 241% higher than in 2021, when it totaled 341 trials. It is expected that in 2023, the number of clinical trials will continue to increase in double digits, growing in volume and complexity of the projects undertaken from Spain. 

Growing Relevance of Advanced Therapies 

Advanced therapies (gene therapy, cell therapy, and tissue engineering) are treatments based on genes (gene therapy) or cells (cell therapy), which may originate from the patient (autologous) or a donor (allogeneic). Along with tissue engineering, CGTs or C&GTs in English form the field of advanced therapies, identifying new therapeutic strategies to treat diseases that currently lack treatment. Currently, CGTs primarily treat genetic diseases, immune system disorders, and certain types of cancer. 

The potential of CGTs in precision regenerative medicine is very high, as it offers solutions to diseases that had poor prognoses with traditional treatments. It is an innovative field in continuous development that entails complex logistical challenges, such as very low-temperature storage or complex supply chains, where Alcura offers innovative solutions.