Strengthening the Reliability of Advanced Therapy Medicinal Products (ATMP) Development: The Role of Cryopreservation in Bolstering Europe's Cell Therapy Supply Network
In a significant move for the cell therapy industry, Cryoport Systems has established a robust presence in Europe with its IntegriCell™ cryopreservation services. These services play a crucial role in supporting the European cell therapy supply chain, ensuring consistent high-quality leukapheresis starting material, which is vital for personalized and time-sensitive cell therapies.
The IntegriCell™ platform, part of an end-to-end supply chain solution, maintains product viability, compliance, and chain of identity from collection through to final administration. This integration helps therapeutic developers reduce risks and meet regulatory requirements in the EU, including Qualified Person (QP) release services.
Cryoport Systems offers integrated solutions that de-risk logistics and promote scalable therapy development and commercialization. By consolidating shipping systems, cryopreservation, biostorage, and expert consulting, the company eliminates supply chain fragmentation, supports audit-ready documentation, and facilitates geographic expansion. This consolidated platform enables developers to confidently scale cell therapies while ensuring patient-specific material integrity and regulatory compliance across Europe.
The IntegriCell™ cryopreservation service is a key component in Cryoport Systems’ comprehensive European cell therapy supply chain platform. It ensures cell material quality, regulatory compliance, and operational resilience necessary for effective clinical development and commercial delivery of cell therapies across Europe.
The expansion of IntegriCell™ cryopreservation services into Belgium underscores a larger industry focus on supporting cell therapies with robust and adaptable supply chain solutions. Access to regional cryopreservation services bolsters logistical efficiency for European CGT developers, and 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.
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 and navigate complexities of scaling more effectively. This development is a significant step towards a future where therapies are available to patients more reliably.
- Gene therapy clinical trials are advancing, with Cryoport Systems' IntegriCell™ platform playing a pivotal role in maintaining cell integrity and meeting regulatory requirements.
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