Cell and gene therapies like CAR-T (chimeric antigen receptor T-cell therapy) and other immunotherapies are transforming patient outcomes and redefining what’s possible in disease treatment. These therapies are powerful, complex, highly individualized, and extremely sensitive to temperature and environmental conditions. That’s where SciSafe comes in. With over 50 million samples stored across our global locations, SciSafe is uniquely positioned to meet the intense cold storage requirements of next-generation innovation.
The Cold Chain Requirements of CAR-T and Immunotherapy
CAR-T therapy and other immunotherapies are not just new but disruptive by design. These treatments are based on living cells harvested, modified, and returned to the patient, making them incredibly personalized and highly fragile.
These therapies often require storage at ultra-low temperatures (ULT), such as -80°C or even in the vapor phase of liquid nitrogen at -150°C or colder. Any deviation from strict environmental controls can compromise the therapy’s viability and risk not only the loss of a costly dose, but also the delivery of the patient’s time-sensitive treatment.
Beyond just temperature, these materials demand:
- Secure chain of custody: Procedures to track every movement and handling event
- Redundant systems: Services to ensure continuous operation during power loss or emergencies
- Validated equipment and processes: Workflows to comply with global regulatory expectations
- Real-time monitoring and alert systems: Visibility to issues before they become problems
What Makes SciSafe the Right Pharmaceutical Cold Storage Partner?
At SciSafe, we’ve built our business around supporting cutting-edge science with purpose-built infrastructure, knowledgeable staff, and a customer-first mindset. We understand that CAR-T products have unique storage needs. CAR-T storage requires rigorous attention to detail, careful documentation, and adapting quickly when research or clinical priorities shift.
Here’s what our biopharma partners expect for their Immunotherapy and CAR-T storage:
Purpose-Built Infrastructure for Advanced Therapies
Every SciSafe facility is designed from the ground up to handle GMP and GxP-compliant storage, with dedicated spaces for ultra-low temperature storage and cryogenic temperature storage. We maintain validated environments with comprehensive 24/7 monitoring systems. Whether your therapy needs -20°C, -80°C, or cryostorage, we have the equipment and the know-how to protect it.
Our facilities feature:
- Backup generators with redundancies
- Alarm systems monitored both locally and remotely
- Redundant HVAC and temperature control systems
- Comprehensive environmental qualification
- 24/7 staff oversight
Regulatory-Grade Quality Systems
Due to their critical therapeutic role and living components, CAR-T and immunotherapy products typically fall under rigorous regulatory oversight. SciSafe operates under a comprehensive Quality Management System that meets FDA, EMA, and global regulatory requirements.
We’re fully audit-ready at all times, and our clients have confidence knowing:
- All systems are validated
- All staff are trained in GMP standards
- SOPs are in place and enforced
- Full traceability is maintained for every sample, every time
- SciSafe has a perfect record of 7 FDA inspections with no 483 findings
We regularly host both client and regulatory audits. Our quality systems have passed inspections from some of the world’s largest and most discerning biopharmaceutical companies.
Customizable Cold Storage Solutions
Many companies have unique storage requirements, so pharmaceutical cold storage solutions can’t be one-size-fits-all. At SciSafe, we offer scalable, tailored solutions based on your specific project needs. Whether you’re working with a few initial patient samples or scaling into commercial distribution, we can adjust capacity, processes, and services without missing a beat.
Do you need same-day access to stored material? Do you want to set up a specific quarantine process for your CAR-T batches? Are you looking for validated LN2 vapor storage with restricted access protocols? SciSafe can do that.
Our job is to make your job easier, especially when it comes to complex materials with high stakes.
Unmatched Customer Service from Experienced Biostorage Experts
Our expert team of GMP specialists and cold chain logistics professionals understand the science and the stakes behind every vial we store. We treat your materials with the same care and urgency that you do, because we know what’s on the line. From onboarding to ongoing operations, you’ll work directly with responsive, knowledgeable staff committed to your success.
The SciSafe Difference: More Than Just Storage
When it comes to CAR-T and immunotherapy, every sample matters, and every detail in the storage process can impact the success of a therapy and a patient’s life.
SciSafe doesn’t just provide cold storage; we provide peace of mind. With proven expertise, cutting-edge facilities, and a capable team, we help biopharma innovators protect their most advanced therapies from lab to clinic.
Want to learn more about how SciSafe can support your CAR-T or immunotherapy program? Contact our team for a custom consultation so we can discuss your pharmaceutical cold storage needs and how to help you get there faster, safer, and more confidently.