New Facilities in Houston, Tx and Villers-le-Bouillet, Belgium Strengthen Cryoport Systems’ Global Leadership in Temperature-Controlled Supply Chain Services
(Houston, Tx, USA and Villers-le-Bouillet, BELGIUM)
Cell therapies are revolutionizing medicine, providing new hope for conditions that were once considered untreatable. However, as the market for advanced therapies expands, ensuring safe and reliable access to sensitive, patient-derived materials has become increasingly challenging. Complex supply chains and logistical barriers can jeopardize the stability of cell therapies, presenting a major hurdle in delivering these innovative treatments to patients.
As the advanced therapies market evolves, 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 patient outcomes. 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.
Cryopreserved leukapheresis material offers substantial advantages. It extends the time window between collection and manufacturing and ensures cell viability and function are maintained despite potential delays1,2,3. This flexibility is crucial as the production of CAR-T cell therapies expand globally, reducing the risk of supply chain disruptions and improving manufacturing efficiency. The adoption of cryopreservation, which has proven efficacious through global clinical trials4,5, helps overcome the challenges associated with fresh leukapheresis and ensures a reliable supply of high-quality starting material for successful therapeutic advancement. Multiple commercially available CAR-T cell therapies have incorporated leukapheresis cryopreservation into their manufacturing process, and global supply chain management teams have begun integrating this approach to facilitate robust drug product manufacturing and support an increasing number of patients.
As a leading provider of temperature-controlled supply chain solutions, Cryoport Systems recently launched its IntegriCell cryopreservation services at facilities in Houston, Texas and Villers-le-Bouillet, Belgium, aiming to reduce variability and uphold the cell quality critical for advanced therapies. The goal of the integrated IntegriCell platform is to provide scalable, standardized cryopreservation options to meet the unique demands of cell therapy logistics by standardizing processes and reducing variability.
Introducing IntegriCell™ from Cryoport Systems: End-to-End Support for a Sustainable Cell Therapy Supply Chain
IntegriCell™ cryopreservation services are designed to deliver consistent, compliant, high-quality leukapheresis starting material essential for cell-based therapies. The services ensure that every batch meets the stringent standards required for successful therapeutic outcomes, significantly reducing variability and enhancing reliability. By leveraging advanced cryopreservation techniques and rigorous quality control measures, IntegriCell maintains the integrity and viability of leukapheresis samples, ensuring that the starting material is always of the highest possible quality.
Cryoport Systems’ newly opened cryopreservation facilities in Houston and Belgium, along with biostorage, consulting services, and temperature-controlled logistics are seamlessly integrated into Cryoport Systems’ end-to-end platform for streamlined operations and maximum efficiency. The Houston facility is located at Cryoport’s renowned Global Supply Chain Campus (GSCC), where the cryopreservation services are offered alongside cGMP biostorage, drug packaging drug labeling, kit protection and logistics capabilities. The Belgian facility functions as Cryoport Systems’ Center of Excellence (CoE) and houses process development, optimization and technology transfer services. Both facilities provide cryopreservation manufacturing for clinical grade/cGMP compliant processes and are capable of cryopreserving over 1,000 leukapheresis products per year.
Standardized for Consistent Quality
IntegriCell applies a standardized cryopreservation process of fresh leukapheresis within an ideal 24 hours from collection, coupled with rigorous quality control measures. This robust and reproducible cryopreservation process maintains the viability and health of the cells, which is essential for the efficacy of the final therapeutic product. The cryopreservation process is automated and conducted in a closed system using the Cue® Cell Processing System (Fresenius Kabi) and combined with CryoStor® CS10 (BioLife Solutions). This method adheres to the principles of Quality by Design (QbD), where the cryopreservation process has been meticulously developed, identifying and optimizing Critical Process Parameters (CPPs) with a thorough risk assessment. Key CPPs, such as the content of the wash buffer solution, cell concentration during processing, and spinning membrane wash flow rates are fine-tuned to ensure consistency and quality of the cryopreserved cells.
A key component of the Cryoport Systems process is the use of this cGMP-compliant, closed automated system. Automation and process closing from the surrounding environment reduces the need for critical interventions in open phases and associated contamination risks, all while increasing reproducibility. The closed automation ensures that each batch of leukapheresis material is handled consistently, minimizing the potential for errors and enhancing overall reliability. By eliminating the variables introduced by manual handling, a higher level of standardization and quality control is achieved, which is essential for producing consistent cell therapy products.
A Comprehensive Technology Transfer
Cell therapy developers may have a preferred cryopreservation process they wish to implement. In these cases, the Process Development and MSAT teams at the IntegriCell Center of Excellence play a pivotal role in ensuring a smooth and efficient technology transfer. Leveraging decades of expertise, the multidisciplinary team works closely with clients to establish and refine cryopreservation processes, facilitating a seamless transition into clinical trials or scaled manufacturing operations. The foundation of the tech transfer process is aligning with each client’s unique needs. Driven by our MSAT team, the project management, technical operations, analytical, and quality assurance teams collaborate to thoroughly evaluate processes and supporting documentation. This approach ensures that all procedures are adapted and optimized for scalability, while maintaining compliance and minimizing variability.
By integrating cryopreservation with a state-of-the-art logistics infrastructure, Cryoport Systems enables cell therapy developers to preserve and deliver manufacture-ready cryopreserved leukopaks with precision and consistency. This integration enhances manufacturing flexibility, streamlines timelines, and supports uninterrupted progress from development to commercialization. IntegriCell provides the expertise, infrastructure, and operational excellence needed to enable successful tech transfer for advanced therapies.
Enabling Manufacturing Efficiency
Historically, cryopreservation has been viewed as a “one-size-fits-all” solution that was often performed at the same center as the collection process. The IntegriCell approach extends the shelf life of cryopreserved starting material, allowing for the decoupling of collection from drug product production and manufacturing. Cryopreserving leukapheresis material within 24 hours post-collection ensures that the quality of the starting material is maintained over time, providing flexibility and efficiency in the manufacturing process. This capability not only supports better planning and resource allocation but also reduces costs and mitigates risks, ultimately expanding access and leading to more successful outcomes in cell therapy development and delivery.
Additionally, IntegriCell™ cryopreservation services help reduce backlogs and logistical challenges that can impede manufacturing success. With the ability to store and utilize cryopreserved materials as needed, advanced therapy developers can better manage their supply chain and production schedules, decreasing the risk of delays and disruptions. This results in enhanced manufacturing success rates and a more streamlined process from start to finish. By maximizing manufacturing efficiency, IntegriCell™ cryopreservation services support the timely and cost-effective development of cell-based therapies
Transport, Storage and Distribution at a Global Scale
IntegriCell features an integrated storage and distribution network that ensures controlled, worldwide transportation of the cryopreserved cells to their manufacturing destination. This network exists within Cryoport Systems’ Global Supply Chain Centers (GSCC), which house logistics, biostorage, and cryopreservation processes from a single location. The cryopreserved material can be stored for both long and short-term durations within our GSCCs then distributed to manufacturing facilities on a scheduled or last-minute timeline to accommodate client needs.
Cryoport Systems’ IntegriCell cryopreservation services expand into an end-to-end model that supports clients’ entire temperature-controlled supply chain. The IntegriCell model combines Cryoport Systems’ standardized cryopreservation services with world-renowned logistics and supply chain expertise to facilitate the timely delivery of manufacture-ready cryopreserved leukopaks to manufacturing sites. The solution includes several critical components that ensure the integrity and quality of the therapy throughout its journey.
At a global scale, the EMEA presence in the Belgian CoE means European-based therapy developers can benefit from Cryoport’s full suite of temperature-controlled supply chain solutions, including state-of-the-art shipping systems and logistics, cGMP-compliant bioservices and biostorage, and industry-leading risk mitigation—all tailored to support the advanced therapies medicinal product (ATMP) pipeline.
The IntegriCell model supports the transportation of leukapheresis from collection centers to the cryopreservation sites housed in the purpose-built Cryoport Express® shipping system. Like all of Cryoport Systems’ diverse shipper fleets, the Cryoport Express® temperature-controlled shippers include our best-in-class condition monitoring system, Smartpak®, that tracks each shipment’s location, temperature, orientation, and other critical aspects. This technology enables constant coverage, and the metrics are accessible to clients within the innovative logistics management system, Cryoportal®. With this insight, clients can ensure their transported materials remain viable from initial collection to the IntegriCell cryopreservation facilities.
Enhanced by Partnerships for Apheresis Sourcing & Collection
Through strategic partnerships, Cryoport Systems significantly enhances its supply chain capabilities to provide access to highly characterized, quality-controlled, manufacture-ready cryopreserved leukopaks. By collaborating with world-renowned organizations, donor material collection and management meets the highest standards. These partnerships offer therapy developers a reliable and consistent supply of top-tier leukapheresis starting material.
These alliances grant access to a pool of over 7 million genetically diverse potential donors and the expansive network guarantees compliance with regulatory standards and maintains the integrity of the donor material throughout the collection process. By leveraging these collaborations, clients have access to the best possible starting material, supporting the advancement of cell and gene therapies worldwide.
As the need for reliable, efficient cryopreservation continues to grow, IntegriCell stands ready to preserve the future of medicine—one cell at a time. This launch marks a significant milestone, bringing a world-class cryopreservation platform to cell therapy developers. As advanced therapies continue to evolve, Cryoport Systems remains at the forefront, ensuring that critical materials reach the patients who need them most.
About Cryoport Systems
Cryoport Systems is a comprehensive supply chain partner for the life sciences industry focused on meeting the challenges of the global cell and gene therapy market. We excel in the specialized management of the biopharma supply chain through our comprehensive offerings in logistics, BioServices and biostorage, cryopreservation, and consulting. With our expansive platform and decades of temperature-controlled supply chain expertise, Cryoport Systems helps Enable the Outcome™ for advanced therapies programs, safely and securely guiding critical therapies to patients in need.
For more information about IntegriCell and how it can support your cell therapy supply chain needs, please visit https://www.cryoport.com/solutions/integricell/.
References
- Qayed, Muna et al. “Leukapheresis guidance and best practices for optimal chimeric antigen receptor T-cell manufacturing.” Cytotherapy vol. 24,9 (2022): 869-878.
- Clarke, Lawrence. “Crypopreservation of the clinical apheresis starting material maintains quality and offers options to extend stability.” Cytotherapy vol. 21,5 (2019): S39-S40.
- Abraham-Miranda, Julieta et al. “CAR-T manufactured from frozen PBMC yield efficient function with prolonged in vitro production.” Frontiers in immunology vol. 13 1007042. 26 Sep. 2022.
- Tyagarajan, Seshu et al. “Autologous cryopreserved leukapheresis cellular material for chimeric antigen receptor-T cell manufacture.” Cytotherapy vol. 21,12 (2019): 1198-1205.
- Brezinger-Dayan, Karin et al. “Impact of cryopreservation on CAR T production and clinical response.” Frontiers in oncology vol. 12 1024362. 6 Oct. 2022
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