CELLSECURE BIO
Frequently Asked Questions (FAQ)
Answers to common questions about our company and services. Need additional information? Contact CellSecure Bio at info@cellsecurebio.com.
General
What services does CellSecure Bio provide?
CellSecure Bio provides:
- Storage Services
- We store and manage storing biological materials, biopharmaceuticals, clinical material, therapeutic cells, and cell banks.
- Cell Therapy Process Development
- Device & Reagent Validation
- Independent evaluation of cell therapy manufacturing devices, analytical equipment, and reagents suitable for therapeutic cell manufacturing.
How can organizations get started with CellSecure Bio?
Contact CellSecure by completing an online form. One of our representatives will contact you directly and gather information to provide a custom quote.
Storage Services
What are the key drivers for storing at an offsite biorepository?
- Risk Mitigation
- Reduces risks from power failures, equipment malfunctions, or natural disasters.
- Disaster Recovery & Continuity Planning
- Protected by redundant systems and geographically separate facilities.
- Capital Expenditure
- Storing at a biorepository eliminates significant capital expenses for purchasing cold storage units, cryogenic systems, backup power, and monitoring systems.
- Operating Costs
- Lower operating costs by reducing maintenance, in-house support staff managing and maintaining specialized equipment, and energy use.
- Specialized Expertise
- Dedicated team trained in regulatory requirements, chain-of-custody, and the handling of temperature-sensitive materials.
- Compliance & Quality
- Support for regulatory and accreditation requirements through controlled environments, documented SOPs, and full traceability.
- Scalability & Flexibility
- Ability to scale capacity quickly and flexible storage timelines, temperature requirements, and volume (box, shelf, rack, or full unit).
- Space Optimization
- Reallocation of internal space for operations or dealing with space constraints.
What types of materials does CellSecure Bio store?
CellSecure Bio provides secure, validated biorepository storage for biological materials, therapeutic cells, cell banks, and clinical material. We support a wide range of temperature conditions, including ambient, refrigerated (2–8°C), frozen (-20°C / -80°C), ultra-low, and cryogenic storage (-150°C to LN₂ vapor).
How is the integrity of stored materials ensured?
Material integrity is preserved through a combination of,
- Validated storage systems
- 24/7/365 temperature and environmental monitoring
- Automated alarms for temperature excursions
- Redundant power
- Onsite backup generator
- Backup at-temperature freezers and refrigerators
- Controlled access
- Documented SOP procedures
Is CellSecure Bio offsite biorepository compliant with regulatory standards?
Yes. Our offsite biorepository operations adhere to industry and regulatory guidelines, including cGMP, FDA standards, ISO, and state regulations. SOP-driven validated workflows, audit-ready documentation, and quality assurance support regulatory inspections and compliance reporting.
Are materials retrieved and distributed quickly when needed?
Yes. Controlled, rapid retrieval and distribution processes ensure materials are handled and transported in a controlled temperature environment in a safe, timely manner.
Who typically uses offsite storage services?
Clients include medical research facilities, academia, biotechnology and pharmaceutical companies, cell and gene therapy developers, CROs and CDMOs, government institutions, and regenerative medicine programs requiring secure, long- or short-term storage.
Where is the biorepository located?
The biorepository is located in Elk Grove Village, Illinois (near O’Hare International Airport)
This location allows us to support local communities and domestic and global cold-chain logistics.
How quickly could CellSecure Bio accept new samples or materials?
Our team responds rapidly to inbound requests and can often support immediate intake, depending on material type, temperature requirements, and logistics.
Can you support commercial-scale cell inventory?
Yes. Our infrastructure is designed to accommodate both early-stage development programs and commercial cell manufacturing.
Cell Therapy Process Development Service
What cell therapy development services do you provide?
CellSecure Bio supports the development of cell-based therapies through process optimization, laboratory support, technical expertise, and scalable, cost-effective solutions designed to accelerate clinical programs.
How does CellSecure Bio cell process development service help reduce risk during cell therapy programs?
Robust planning, validated procedures, quality systems, and technical oversight help improve consistency, minimize variability, and support successful technology development.
Can CellSecure Bio services be customized to meet our research or manufacturing requirements?
Yes. We work closely with organizations to develop customized solutions that align with specific research objectives, manufacturing processes, regulatory requirements, and project timelines.
Will we own the final process documentation?
Cell Therapy Device & Reagent Validation Service
Why is validation important for new cell therapy devices and reagents?
Validation helps demonstrate that equipment, consumables, and reagents consistently perform as intended, reducing operational risk while supporting product quality and regulatory compliance. Such validation is needed for new equipment and reagents before being introduced into the market.
What types of devices and reagents can you assess and validate?
We evaluate a wide range of cell therapy manufacturing devices and reagents, as well as related technologies used throughout cell therapy development and manufacturing.
How does CellSecure Bio validation process support regulatory requirements?
Our validation approach generates documented performance data, standardized testing protocols, and objective evaluations that help organizations support internal quality requirements and prepare for regulatory IND submissions.
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