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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 storage 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 SOPs guide every step of the biorepository process, helping ensure consistency, compliance, and sample viability across:
Each sample is barcoded, scanned, and registered in our LIMS to ensure chain-of-custody and minimize variability in handling.
Samples are stored via the appropriate requirements with continuous monitoring through our Rees™ system, which offers several redundancies and backup systems.
Samples are retrieved upon request via our secure portal and delivered to the designated location with documented chain-of-custody.
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.
