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GxP compliant storage solutions for sensitive materials in research, clinical, pharmaceutical, biotech, and other regulated fields.
Protecting Discovery Through
As biological research and development accelerate across clinical trials, cell and gene therapies, and precision medicine, the role of secure, compliant, and scalable biorepositories is more critical than ever.
GenVault was purposefully built to meet this need. With security features engineered into the infrastructure itself, a five-floor GxP-compliant facility, and proven scalability, GenVault delivers dependable sample storage, sample management, and logistics services designed to protect the future of science.
In addition to GenVault’s standard operating procedures and advanced facility infrastructure, we have also earned several voluntary accreditations that underscore our commitment to quality and compliance.
GenVault’s adherence to ISO 9001 ensures our quality management system (QMS) consistently meets both customer expectations and regulatory requirements.
This includes documented procedures, continuous improvement, and comprehensive compliance.
This international standard for biobanking validates GenVault’s impartiality, technical competence, and consistency across all aspects of sample handling, facility operations, and quality assurance.
The College of American Pathologists (CAP) sets the gold standard for laboratory accreditation. GenVault’s CAP accreditation confirms our laboratory operations meet or exceed the most rigorous standards for quality and consistency.
These accreditations support our full compliance with relevant U.S. federal regulations, including:
GenVault’s infrastructure and SOPs are designed to meet these regulatory requirements, offering clients both assurance and audit readiness.
Choosing the right biorepository starts with a thorough audit. GenVault supports in-person, virtual, and third-party audits, and will provide full documentation on:
Our GxP-compliant biorepository can hold more than 150,000,000 samples and can accommodate a wide variety of secure, temperature-controlled storage conditions.
Our five-story biorepository can house more than 150 million samples.
Samples can be requested via LIMS and delivered quickly anywhere in the nation, with the fastest turnaround times available in the Philadelphia, New York and Baltimore/DC areas.
GenVault’s storage facility has 12-inch impermeable walls, ESFR Preaction Suppression Systems on every floor, and roof-embedded ESFR sprinklers.
Our facility offers temperatures from ambient to cryogenic, including 30℃, 4℃, -20℃, -80℃, -196℃, as well as ICH-compliant stability chamber storage. Contact us to discuss custom solutions to your unique needs.
Facilities are secured with 24/7 monitoring, facial recognition, prohibited-person alerts, and badge-restricted access.
GenVault incorporated backup diesel-fuel generators into the power grid in addition to other tertiary backup power systems.
GenVault offers a comprehensive range of sample storage conditions to meet the needs of diverse research and regulated industries. Our GxP-compliant biorepository supports ambient (15–30°C), Controlled Room Temperature (20–25°C), cold room (2–8°C), freezer (-20°C), Ultra-Low Temperature (-80°C), and cryogenic (-150 to -196°C) storage — all within a single, five-floor facility capable of housing more than 150 million samples.
Our sample management services are built on a foundation of rigorous compliance. GenVault is ISO 9001 certified, ISO 20387 accredited, CAP-accredited, and registered with the FDA as a Third-Party Logistics Provider (3PL) and a Human Cell and Tissue Establishment (HCT/P establishment), meaning our processes meet the highest standards for quality and consistency. We operate in full accordance with 21 CFR Part 11, 21 CFR Part 211, current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP), providing clients with complete audit readiness at every stage of sample management.
GenVault’s sample management and sample storage solutions serve a broad range of clients, including pharmaceutical and biotech companies, clinical trial sponsors, cell and gene therapy developers, academic research institutions, foundations, CDMOs, CROs, and government agencies. Any organization that requires secure, temperature-controlled, and compliant storage for biological or chemical materials can benefit from our services.
Sample storage security at GenVault is engineered into the facility itself. Our building features 12-inch impermeable walls, ESFR Preaction Suppression Systems on every floor, and roof-embedded ESFR sprinklers. Access is controlled through badge restriction, facial recognition technology, and prohibited-person alerts, all backed by 24/7 monitoring — ensuring the safety and integrity of every sample in our care.
From the moment a sample arrives at our facility, our sample management process ensures complete traceability. Each sample is individually barcoded, scanned, and registered in our Laboratory Information Management System (LIMS). Continuous environmental monitoring is maintained through our Rees™ system, which is hard-wired to eliminate risk from Wi-Fi outages. All outgoing shipments are documented with a verified chain-of-custody — so clients have full visibility and confidence at every step.
GenVault has built multiple redundancies directly into our sample storage infrastructure to protect against disruptions. Our facility operates on backup diesel-fuel generators integrated into the power grid, along with additional tertiary backup power systems capable of running for up to 14 days without recharging. This ensures uninterrupted, cGMP-compliant storage conditions even in the event of a power outage or equipment issue.
GenVault engineers disaster readiness through structural resilience and a comprehensive Business Continuity and Disaster Recovery (BC/DR) plan designed for grid independence. Our purpose-built facility features 12-inch reinforced walls engineered to withstand earthquakes, flooding, and fires, as well as hurricanes and extreme weather. We maintain 14 days of power continuity via redundant generators to protect critical sample management workflows and storage conditions during catastrophic events.
