Bio Storage Solutions

Biorepositories will play a considerable role in the progress of biological research and development. The industry is projected to experience double-market growth and significant capital investment, allowing endless opportunities for innovation and development. This expansion will require biorepositories that maintain the integrity and security of this influx of biological samples.
GenVault was built by industry experts to be one of the nation’s most secure commercial biorepositories, incorporating security features directly into the infrastructure. The resulting facility is a state-of-the-art, GxP-compliant biorepository that can preserve and protect biosamples in a wide range of storage conditions. GenVault’s cold chain storage experts will also serve as an extension of our client’s team by providing end-to-end bio inventory support and unparalleled customer service.

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GenVault Standard Operating Procedures

All biorepository operations must be optimized to ensure the samples are maintained and fit for research or clinical use. These standard operating procedures (SOPs) help the biorepository personnel with the proper accession and storage of the samples to guarantee their quality. The operations of GenVault’s biorepository are:

Intake Processing

New samples are recorded in the collection by scanning a barcode and then entering the sample information into a LIMS. This standardized intake method also ensures that all our clients’ samples are treated the same, minimizing any variation due to handling techniques.

Storage

The appropriate storage requirements are identified, and the sample is stored in the corresponding temperature-controlled freezer. LIMS and our Rees temperature monitoring system offer several redundancies and backup systems, ensuring sample owners will be contacted immediately and will receive alerts in real-time should a mechanical failure take place. Our experts will work to find the proper solution, whether it be safely transporting samples to another storage unit at our facility or deploying technicians to quickly repair the unit.

Return of Samples

When our clients request the return of samples through our secure client portal, they are quickly and efficiently retrieved from storage and then transported back to the requested location.

Storage Solutions

Our GxP-compliant biorepository can hold more than 60,000,000 samples and can accommodate a wide variety of secure, temperature-controlled storage conditions.

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Ample Space

Our biorepository can store 60M+ samples in 6 floors, with 1K+ units for extremely low temperatures and walk-in cold rooms.

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Quick Access

Samples are available during business hours. Request sample access via LIMS system. Sample delivery within 2 hrs of request.

Building Protection

GenVault’s storage facility has 12-inch impermeable walls, ESFR Preaction Suppression Systems on every floor, and roof-embedded ESFR sprinklers.

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Storage Conditions

Our facility offers temperatures from ambient to cryogenic, including 30℃, 4℃, -20℃, -80℃, and -196℃ to meet all sample needs.

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Security Measures

We secure samples with 24/7 monitoring, facial recognition, prohibited persons alerts, and badge-restricted access to prevent unauthorized entry.

Backup Methods

GenVault incorporated backup diesel-fuel generators into the power grid in addition to other tertiary backup power systems.

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Voluntary Accreditations

In addition to GenVault’s standard operating procedures and state-of-the-art facility features, GenVault has also earned several voluntary accreditations to ensure the highest level of quality and regulatory compliance. These accreditations include:

ISO 9001 Registered: This standard outlines the criteria for a quality management system (QMS) that ensures the consistent provision of products and services that meet both regulatory and customer requirements by demonstrating compliance with the standard’s guidelines, meeting their own requirements, maintaining documentation, and fulfilling customer, statutory, and regulatory requirements. GenVault’s adherence to these standards ensures that operations consistently meet customer and regulatory requirements.

ISO 20387 Accredited: Serving as the international benchmark for ensuring confidence in biobanking practices, this accreditation encompasses all aspects of biobank management, including personnel, facilities, equipment, structural and process management, and quality management systems. GenVault’s strict adherence to requirements for impartiality, competence, and consistent operations in sample handling ensures the integrity of samples.

CAP Accreditation – GenVault’s laboratory is also accredited by the College of American Pathologists (CAP), which is recognized as the gold standard in laboratory accreditation. This accreditation indicates that GenVault’s laboratory meets or exceeds the highest standards for quality and laboratory practices.

By earning these accreditations, GenVault adheres to the following government regulations:

21 CFR Part 11, Electronic Records; Electronic Signatures
21 CFR Part 211, Current Good Manufacturing Practices
21 CFR Part 59, Good Laboratory Practices

GenVault demonstrates our commitment to providing our clients with the highest quality and regulatory compliance. These accreditations also provide independent verification of our expertise, capabilities, and commitment to quality, making us a trusted biorepository partner.

In-Depth Audits

Choosing the right biorepository should begin with a comprehensive audit to ensure quality and capability. GenVault will provide a full audit of our processes and documented procedures that will include the following:

Quality Management System (QMS)
Regulatory registrations
Current Good Management Practices (cGMP)
Good Clinical Practice (GCP)
Good Laboratory Practices (GLP)
ISBER compliance
Client material traceability and management

Storing with GenVault

We understand how invaluable biological products and samples are to experimentation and development efforts. An effective and reliable preservation facility requires quality equipment, adaptable space, and expert tracking and monitoring—all factors incorporated into GenVault’s storage facility design. No other commercial biorepositories have the security and sample integrity found with GenVault. If you have any questions, contact us today to discuss how a secure, off-site biorepository can support your organization. We can also discuss our comprehensive bio-transport services if your organization is storing samples in anticipation of a facility location move.