Biostorage Services

 

Vigilant Bioservices specializes in biomaterials storage, sample management and cold chain logistics.


Clinical Materials
Patient Samples
Legal Retains/Archive Samples
Human Cell/Tissue-based Products
Biologic Raw Materials
Intermediates and Finished Goods Inventories.

Stability Storage

VB eliminates the need for you to invest in specialized storage equipment and infrastructure enabling you to focus on discovery, development, and manufacturing. VB offers stability services for companies looking to store materials per ICH Guidelines and perform their own testing. We use state of the art CARON chambers.

 

Photostability Features:

UV Full ICH Exposure at approximately 8 hours

VIS Full ICH Exposure at less than 48 hours

Timed test at virtually any UV or VIS intensity

 

Send us your samples on Monday morning and you will receive them back by Friday afternoon.  


Temperature/Humidity setpoints include:
25°C/60%RH
30°C/65%RH
40°C/75%RH
Cold Storage (5C, -20C, -30C, -50C, -80C, and Vapor Phase Liquid Nitrogen)

Additional custom setpoints are available at request. Our staff will work with your specific stability program needs and create a customized client protocol to address storage, receipt verifications, pull procedures, and transport. Sampling of the benefits afforded to our clients:

* Reduces capital costs by eliminating the need to purchase equipment for specific Temp/RH conditions and infrequent studies
* Reduces FTEs to calibrate, validate, perform Preventative Maintenance (PM) and manage daily inventory along with QA oversight and review of all activities
* Reduces risks to integrity of stability studies due to power failure, equipment malfunction, etc.
* Provides scalability to manage costs without new equipment and overhead requirements.

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Clinical Sample Management

We recognize that samples collected during preclinical or clinical trials are crucial data that cannot be replaced. As such, we have put in place quality controls to preserve sample identity, integrity and provide thorough traceability documentation.

Our service offerings for clinical samples include the following storage conditions:
<-135°C (vapor phase LN2)
-80°C
-30°C
-20°C
2-8°C (refrigerated storage)
Ambient

* Logistics and storage of biological samples
* Inventory and storage of mounted slide blocks and slides
* Inspection and verification of sample identity and label integrity
* Storage of archive samples
* Coordination of shipments from clinical sites.

Long Term Storage

VB specializes in archival Long Term Storage. We enable organizations to satisfy risk mitigation strategies with offsite freezer space that avoids the purchase of new equipment with state-of-the-art, safe storage.

Ask us about our creative pricing strategies for multi-year storage for any storage temperature. For growing companies, we offer Fractional Freezer Pricing, enabling volume discounts and protections against runaway costs.

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Cell Banking Storage

Master and Working Cell Banks are critical for biologics development; specialized handling and inventory controls are necessary to ensure their identity, purity and viability. Because of their critical nature, manufacturers typically rely on cell bank redundancy in the event of loss or degradation of the Working Cell Bank.

Our service offerings for cell banking include these storage conditions:
<-135°C (vapor phase LN2)
-80°C

* Inventory and storage of cell banks vials
* Inspection and verification of sample identity and label integrity
* Long-term storage of archive samples

Tissue Banking

Our management team has over 30 years of combined experience in all aspects of human cell and tissue-based product (HCT/P) operations. This foundation gives us the technical expertise to assure effective compliance in storage and distribution of tissue products.

Our service offerings for tissue banks include these storage conditions:
-80°C
-30°C
-20°C
2-8°C
Ambient

* Logistics and storage of unprocessed quarantine issues
* Inspection and verification of recovered tissues
* Donor blood and tissue sample verification and management
* Storage of archive samples
* Coordination of shipments to processors
* Storage and inventory of Work In Process quarantine inventory
* Storage, inventory and shipping of relased HCT/Ps
* Shipping container and product packaging validation
* Dedicated contingency space for emergency storage of tissue.

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Bottom Line?  See how we work with our clients.