Context
We assisted a global leader in the pharmaceutical industry in expanding its network and capacity to accelerate growth in advanced therapies. To achieve this, the company planned the integration of a state-of-the-art central cryopreservation site, designed to securely store and manage cryopreserved materials essential for Advanced Therapy Medicinal Product (ATMP) studies. This expansion reinforced the client’s commitment to delivering personalized medicine through a seamless vein-to-vein process, ensuring patient-specific materials are efficiently collected, preserved, and delivered for transformative treatments.
Ambition: Strengthening supply chain resilience for advanced therapies
The integration of the cryopreservation center offered a significant opportunity to strengthen the advanced therapies logistics network. Aligning the center’s internal operations with ATMP requirements allowed for enhanced process standardization and quality control. Additionally, navigating complex regulatory frameworks, managing import and export compliance, and maintaining a secure chain of identity and custody for sensitive human materials opened the door to building a resilient and fully compliant supply chain. Seamless courier integration further supported the client’s goal of delivering safe and timely patient-specific therapies.
How we helped
We supported the client with the integration of the new cryopreservation center by clearly defining project scope and aligning operations with ATMP standards. Key actions included outlining roles and responsibilities, supporting with the selection of premium logistics partners and establishing a robust logistics flow for cryogenic shipments. We assisted in preparing all necessary shipping documentation, set up clear communication channels, and provided training to all involved stakeholders ensuring smooth operations and compliance.
Results
The cryopreservation center was successfully integrated into the existing ATMP network, emphasizing the client’s capacity for ATMP studies. A new partnership was established, enabling reliable, compliant logistics for cryopreserved materials while upholding the chain of identity and custody. This integration ensured seamless operations and regulatory adherence, providing the client with a stable foundation for future ATMP expansions.
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