Increasing Demand for
CAR-T
The growing list of FDA-approved CAR (Chimeric Antigen Receptor)-T cell therapies represents groundbreaking advancement to harness the power of a patient’s own T cells to build an individual immune response and combat diseases like cancer. Since 2017, the FDA has granted approval to multiple CAR-T cell therapies for the treatment of various blood cancers, spanning lymphomas, certain types of leukemia, and multiple myeloma. These therapies encompass treatments for:
- Primary mediastinal B-cell lymphoma
- High-grade B-cell lymphoma
- DLBCL arising from follicular lymphoma
- Follicular lymphoma
- B-cell acute lymphoblastic leukemia for both pediatric and adult patients
- Mantle cell lymphoma
CAR-T Handling and Storage
Ensuring the efficacy and safety of CAR-T treatments demands meticulous handling and storage. From shipping these samples and therapies at cryogenic temperatures to accessioning and managing patient-specific sample inventories, logistical planning can make or break a treatment regimen. The full CAR-T treatment process may involve multiple steps, requirements, tools, quality checks and other protective measures to safely treat the patient, but the process generally flows through these four steps:
SciSafe’s Second Dose CAR-T Storage Solutions
At SciSafe, we focus on providing comprehensive solutions for the storage of second dose CAR-T therapies, ensuring the integrity and viability of these delicate samples for the short or long term.
Through partnerships with top global biopharmaceutical companies, we have expanded our second dose storage capacity to accommodate tens of thousands of patient samples. Our commitment to excellence is demonstrated through adherence to high-quality standards and continuous improvement in CAR-T related services.
Our trained technicians ensure the safe handling of CAR-T products, maintaining cryogenic temperatures throughout transportation and storage. We utilize validated dry shippers like the evo® DV10 for secure sample transport with continuous temperature monitoring.
We offer comprehensive logistics support, including IATA-compliant dock transfers, hand-delivered samples in liquid nitrogen, and 24/7 retrieval services. This includes inventory management, storage, and shipment coordination to ensure seamless operations.
Second dose CAR-T samples undergo rigorous accessioning processes to ensure accurate documentation and digital storage of chain of custody and inventory manifests. Patient-specific information is securely managed, complying with HIPAA protocols.
SciSafe maintains stringent quality control measures in accordance with U.S. FDA requirements. This includes triple sample inspections, temperature monitoring data validation, and adherence to manufacturer-specific protocols. Regular audits and documentation verification ensure regulatory compliance and high-quality storage standards.
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Case Study
SciSafe Second Dose CAR-T Storage Case Study
Class-defining solutions for biological and pharmaceutical storage.