Newsletter Signup - Under Article / In Page
"*" indicates required fields
Advanced therapy medicinal products (ATMPs) are pushing the boundaries of medicine, offering hope for previously untreatable conditions. But as Europe’s ATMP landscape grows, the challenge of safely and reliably transporting sensitive, patient-derived materials across borders has intensified. Complex supply chains and logistical barriers can disrupt the stability of cell therapies, presenting a major hurdle in delivering these innovations to patients.
As the cell and gene therapy (CGT) market grows, the need for high-quality, consistent starting material is essential. Many cell-based therapies, such as CAR-T treatments, depend on the stability and viability of leukopaks to achieve successful outcomes for patients. These leukopaks contain a concentrated mix of peripheral blood mononuclear cells (PBMCs) collected from healthy donors or patients through a process called leukapheresis, which selectively isolates white blood cells. Since fresh leukopaks typically have a stability window of just 24 to 48 hours before cell viability declines, maintaining consistent quality during handling and transport is crucial. Cryopreservation offers a solution, helping to stabilize and extend the usability of these materials, which reduces variability and better supports the ATMP supply chain.
As a leading provider of temperature-controlled supply chain solutions, Cryoport Systems is building on its IntegriCell™ cryopreservation services, currently available in Houston, Texas and now also in Villers-le-Bouillet, Belgium, aiming to reduce variability and uphold the cell quality critical for Europe’s growing ATMP pipeline. The goal is to provide scalable, standardized cryopreservation options to meet the unique demands of cell therapy logistics.
Table of contents
Standardizing cryopreservation for global scale
Standardizing cryopreservation processes is essential for maintaining cell viability and minimizing variability across different manufacturing and clinical sites, particularly as the CGT market scales globally. IntegriCell™ cryopreservation services use an automated, closed system to cryopreserve cellular starting materials in a highly controlled, reproducible way, reducing risks of contamination and inconsistency that can impact treatment efficacy. Cryopreserved materials maintain their viability over longer periods, offering developers greater flexibility in scheduling and manufacturing—an especially valuable approach for complex ATMP programs operating under strict regulatory and quality standards in Europe.
Cryopreservation centers strategically located in regions like Belgium and the U.S. enable seamless integration with global supply chain networks, allowing therapy developers to access a consistent set of resources across facilities. By having cryopreservation capabilities in both Europe and the U.S., developers can more easily adhere to standardized protocols for temperature-controlled shipping, GMP-compliant biostorage, and quality assurance—critical elements in supporting the complex CGT pipeline from clinical trials to commercialization. This geographical reach helps ensure that CGT materials maintain quality and compliance across all stages of production and distribution.
Supporting the European supply chain
Cryopreservation solutions play a key role in localizing Europe’s cell therapy supply chain, allowing sensitive materials to be stored, preserved, and transported with minimal disruption. By integrating IntegriCell™ cryopreservation services directly within Europe, developers benefit from reduced transport distances, which lowers the risks and costs associated with long-haul shipments. This proximity allows European therapy developers to respond more nimbly to scheduling needs and regulatory requirements, as well as to avoid potential delays that might compromise the quality of delicate materials.
Beyond proximity, a localized cryopreservation center in Europe ensures that high standards of temperature control, biostorage, and compliance are accessible within the region. This support is especially critical as developers move their therapies from research phases into large-scale trials and, eventually, commercial distribution. Access to regional cryopreservation services not only bolsters logistical efficiency but also provides European CGT developers with essential infrastructure to manage growing patient demand, ensuring that each stage of the cell therapy process— from starting materials to delivery—is as seamless and secure as possible.
A commitment to innovation
The expansion of IntegriCell™ cryopreservation services into Belgium underscores a larger industry focus on supporting cell therapies with robust and adaptable supply chain solutions. By establishing local cryopreservation capabilities, Europe’s CGT sector gains access to standardized, efficient processes that address the practical challenges of ensuring consistent, high-quality starting materials and managing complex logistics across borders. This continued investment in infrastructure not only meets the immediate logistical needs of the ATMP field but also reflects a broader industry commitment to fostering innovation that supports the scale and precision these therapies demand.
The future of cell therapy in Europe
With cryopreservation capabilities now available within Europe, the CGT community can look forward to a more resilient supply chain that prioritizes cell quality and regulatory compliance. Localized cryopreservation resources allow therapy developers to enhance quality control while navigating the complexities of clinical and commercial scaling more effectively. As the demand for cell therapies increases, resources like these are essential in addressing logistical challenges and ensuring that patients in need receive treatments more reliably.
By building a geographically diverse network of cryopreservation facilities, the cell therapy industry is making strides toward a future where therapies are available to patients more quickly and consistently, reinforcing the importance of continued innovation and infrastructure in achieving long-term goals for patient care.
Learn more about how IntegriCell cryopreservation services from Cryoport Systems optimize leukapheresis-derived cell therapies by enhancing the safety, quality, and viability of manufacture-ready cryopreserved leukopaks.
Image Courtesy: Cryoport Systems
