Boosting Harmony in Advanced Therapy Manufacturing: The Role of Cryopreservation in Enhancing Europe's Stem Cell Treatment Distribution Network
In a significant development for the cell and gene therapy (CGT) industry, Cryoport Systems has expanded its IntegriCell™ cryopreservation services into Belgium, localizing the cryopreservation capabilities within Europe [1][2][4]. This move prioritizes cell quality and regulatory compliance, ensuring high standards of temperature control, biostorage, and compliance.
Cryoport Systems, a leading provider of temperature-controlled supply chain solutions, is supporting the European CGT supply chain by providing consistent, high-quality leukapheresis starting material through standardized, automated cryopreservation processes [1][4]. The IntegriCell™ platform operates with Automated Closed Processing (ACP), enabling certified, scalable preservation of temperature-sensitive leukapheresis-derived biologics, which are critical raw materials in cell and gene therapy manufacturing [1][4].
The expansion of IntegriCell™ cryopreservation services reflects a larger industry focus on supporting CGTs with robust and adaptable supply chain solutions. By integrating IntegriCell™ cryopreservation with a global logistics network, Cryoport ensures cold chain integrity for cell therapy materials upstream of manufacturing, reducing supply chain complexity and accelerating clinical readiness across Europe [1][2].
In addition to cryopreservation services, Cryoport offers consulting and advisory services addressing packaging qualification, lane validation, and global regulatory alignment tailored for European markets. These services help gene and cell therapy developers navigate and comply with stringent EU regulations [1][2].
Cryopreservation solutions are integrated within Europe to localize the cell therapy supply chain, offering developers greater flexibility in scheduling and manufacturing. By maintaining cell viability over longer periods, cryopreservation helps stabilize and extend the usability of cellular starting materials, reducing variability [3].
Building a geographically diverse network of cryopreservation facilities is a step towards a future where therapies are available to patients more quickly and consistently. Localized cryopreservation resources enhance quality control and navigate complexities of clinical and commercial scaling more effectively [5].
IntegriCell™ cryopreservation services use an automated, closed system for highly controlled and reproducible cryopreservation. This approach is crucial in the growing CGT market, particularly for complex Advanced Therapy Medicinal Products (ATMP) programs operating under strict regulatory and quality standards in Europe [6].
Moreover, cryopreservation offers a solution for the challenge of safely and reliably transporting sensitive, patient-derived materials across borders in the growing European ATMP landscape. Reduced transport distances through local cryopreservation centers lower risks and costs associated with long-haul shipments [7].
Cryopreservation centers strategically located in regions like Belgium and the U.S. enable seamless integration with global supply chain networks. Standardizing cryopreservation processes is essential for maintaining cell viability and minimizing variability across different manufacturing and clinical sites [8].
In summary, IntegriCell™ supports the European supply chain by standardizing and safeguarding the cryopreservation of critical leukapheresis material through an integrated platform of automated processing, validated cold chain shipping, regulatory alignment, and global logistics expertise [1][2][4]. This end-to-end approach—from collection, cryopreservation, storage, to temperature-controlled transport—enables reliable, scalable, and compliant supply chain operations in Europe, supporting clinical trials and commercial distribution of cell and gene therapies while maintaining product quality and minimizing logistical risks inherent to advanced therapies [1][2][4].
References: [1] Cryoport Systems. (2021). Cryoport Systems Announces Launch of IntegriCell™ Cryopreservation Services in Europe. Retrieved from https://www.prnewswire.com/news-releases/cryoport-systems-announces-launch-of-integricell-cryopreservation-services-in-europe-301309715.html
[2] Cryoport Systems. (2022). Cryoport Systems to Present at the 33rd Annual J.P. Morgan Healthcare Conference. Retrieved from https://www.prnewswire.com/news-releases/cryoport-systems-to-present-at-the-33rd-annual-j-p-morgan-healthcare-conference-301442624.html
[3] Cryoport Systems. (2020). Cryoport Systems Announces Expansion of IntegriCell™ Cryopreservation Services into Europe. Retrieved from https://www.prnewswire.com/news-releases/cryoport-systems-announces-expansion-of-integricell-cryopreservation-services-into-europe-301089476.html
[4] Cryoport Systems. (2021). Cryoport Systems Announces Launch of IntegriCell™ Cryopreservation Services in Europe. Retrieved from https://www.prnewswire.com/news-releases/cryoport-systems-announces-launch-of-integricell-cryopreservation-services-in-europe-301309715.html
[5] Cryoport Systems. (2020). Cryoport Systems Announces Expansion of IntegriCell™ Cryopreservation Services into Europe. Retrieved from https://www.prnewswire.com/news-releases/cryoport-systems-announces-expansion-of-integricell-cryopreservation-services-into-europe-301089476.html
[6] Cryoport Systems. (2021). Cryoport Systems to Present at the 33rd Annual J.P. Morgan Healthcare Conference. Retrieved from https://www.prnewswire.com/news-releases/cryoport-systems-to-present-at-the-33rd-annual-j-p-morgan-healthcare-conference-301442624.html
[7] Cryoport Systems. (2020). Cryoport Systems Announces Expansion of IntegriCell™ Cryopreservation Services into Europe. Retrieved from https://www.prnewswire.com/news-releases/cryoport-systems-announces-expansion-of-integricell-cryopreservation-services-into-europe-301089476.html
[8] Cryoport Systems. (2021). Cryoport Systems Announces Launch of IntegriCell™ Cryopreservation Services in Europe. Retrieved from https://www.prnewswire.com/news-releases/cryoport-systems-announces-launch-of-integricell-cryopreservation-services-in-europe-301309715.html
- The expansion of IntegriCell™ cryopreservation services by Cryoport Systems into Belgium signifies a growing focus on gene therapy, enabling robust and adaptable supply chain solutions for medical-conditions treated by cell and gene therapy across Europe.
- By integrating IntegriCell™ cryopreservation with its global logistics network, Cryoport Systems aims to reduce supply chain complexity and accelerate clinical readiness of biotech advancements in cell therapy manufacturing through science-driven, high-quality leukapheresis starting material.
- This scalable, certified preservation of temperature-sensitive leukapheresis-derived biologics using Automated Closed Processing (ACP) aligns with the stringent EU regulations governing gene therapy and health-and-wellness applications in Europe.
