Biorepository and Cell Therapy Process Development Services Built for Regulatory Success
In the rapidly evolving field of personalized medicine, critical elements for successful implementation include a reliable storage program, a scalable manufacturing process, and a rigorous quality system. Improved patient outcomes depend on excellence in these three main areas.
Advancing scientific discovery requires trusted partners who understand the complexity and support evolving program needs. Our solutions are designed to help the industry protect valuable assets, improve operational efficiency, and advance programs with confidence.
Specialized biorepository, therapeutic cell repository, cell therapy process development, and validation services built for innovators and cell & gene therapy developers who need reliability, compliance, and proven expertise.
Preserve Discovery-Phase Materials
Secure preservation of research samples critical to discovery and translational science, including but not limited to tissues, DNA/RNA, proteins, reagents, viable cells, cell pellets, and engineered cell lines.
Reliable Storage for Material Integrity & Patient Safety
Validated storage solutions for the preservation of cellular therapy material. Designed to meet regulatory compliance and ensure material integrity.
Safe, Secure Cryopreservation
Preserve regenerative therapeutic materials and Standard-of-Care cellular therapy products, including CAR-T, using redundant vapor-phase cryostorage systems compliant with all state and federal regulations.
Long-Term Protection for Cell Lines
Safeguard Master Cell Banks (MCB) and Working Cell Banks (WCB) to ensure reproducibility, safety, reliability, and regulatory compliance.
Bring Novel Personalized Cell Therapies to Patients
Transform cell therapy ideas into life-saving treatments, offering customized solutions for process development, analytical method creation, and manufacturing scale-up.
Ensure Reliable Performance and Reproducibility
Independent performance-qualifying service with documented evidence that cell manufacturing devices and reagents are suitable for their intended use and will consistently meet predefined specifications. We help maintain the highest standards of product quality for patient safety.
CellSecure Bio provides validated, continuously monitored storage conditions across multiple temperatures for short- or long-term preservation of biological, clinical, and cellular materials.
CellSecure Bio is more than a storage provider — we are a strategic partner in preserving irreplaceable biological material and cellular therapies.
Validated Storage Temperatures
Our facility supports multiple validated storage environments.
Expertise Across the Cell Therapy Development Lifecycle
Accelerate development with a process designed for scalability, reproducibility, and regulatory readiness.
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Ensure every critical component performs as intended.
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Working with one experienced partner simplifies project management, improves communication, and creates continuity throughout the development lifecycle.
Most organizations have different scientific, operational, and regulatory needs. We develop customized storage, validation, and development strategies that align with workflows, timelines, scalability requirements, and long-term business objectives.
By partnering with CellSecure Bio and its experienced team, organizations improve operations, strengthen quality, and advance programs. Our goal is to minimize delays, resource constraints, and compliance risk.
Our facilities operate under documented quality systems designed to support audits and data integrity. Controlled access, validated environments, and complete documentation help maintain compliance requirements.
At CellSecure Bio, a dedicated biorepository technician manages clients’ materials, works closely with each account, and serves as a single point of contact for all storage needs. We oversee every aspect of material handling, inventory, documentation, continuous monitoring, and distribution to ensure adherence to best practices and preserve the integrity of stored materials.
| Storage Type | Purpose / Materials | Typical Temperature Conditions | Key Features & Benefits |
|---|---|---|---|
| cGMP Biological Storage | Biological and Research Material | Controlled Ambient, +2 to 8°C, -20°C, -80°C, -135°C to -190°C LN₂ (Vapor Phase) and -196°C LN₂ Liquid Phase) | Flexible storage for a wide variety of materials, continuous monitoring, chain-of-custody, secure and compliant environments |
| Clinical Storage | Clinical trial research material and clinical cell products | -80°C, -135°C to -190°C LN₂ (Vapor Phase) | Regulatory-ready, short- and long-term storage, traceability, audit-ready, and support multi-site clinical programs |
| Therapeutic Cell Cryostorage | Autologous/allogeneic cell therapies, CAR-T, genemodified cells | -80°C, -135°C to -190°C LN₂ (Vapor Phase) | Preserves viability, potency, and function of sensitive cell therapies, business continuity programs, transitional, and archival storage |
| Cell Bank Storage | Master Cell Banks (MCBs), Working Cell Banks (WCBs), and engineered cell lines | -80°C, -135°C to -190°C LN₂ (Vapor Phase) | Long-term preservation for research and manufacturing, cGMP-compliant, multi-site redundancy, audit-ready documentation |
Tell us about your storage needs or current process challenges. Our team will respond with a clear next step.
