• A facility capable of storing specimens at a wide range of temperatures including ambient (20–25 °C), cold room/refrigerated (2–8 °C), ultralow and ultracold (−20 to −95 °C), and vapor-phase nitrogen (−135 to −190 °C).

• Reliable, state-of-the-art, industrial-grade freezers and refrigerators with modern temperature monitoring equipment

• The ability to locate, retrieve, and ship one or many samples on demand

• Sophisticated, redundant power and data backup systems

• Secure facilities with sophisticated smoke detection and fire suppression systems

• Card-controlled access, video surveillance, burglar alarms, and other physical security measures

• Compliant, validated equipment, processes, and software systems that provide real-time access

• Business-continuity and disaster-response plans

• Service-level agreements with guaranteed sample retrieval and shipping response times

• A strategic geographic location away from natural disaster zones and close to convenient and cost-effective transportation and shipping options

• Dedicated, available storage space to accommodate growth and emergency storage needs.

The company searched to identify a partner with a specific focus on long-term sample storage and online sample tracking capabilities. A team thoroughly reviewed several market options, comparing services offered with the needs of their company. Millennium ultimately selected BioStorage Technologies (BST). Its compliance with good laboratory practices helps ensure high sample integrity, security, and control with “24/7” visibility. The company's Web-based Intelligent Specimen Inventory Storage System (ISISS) tracks sample history and storage temperatures during every step of shipment and storage in real time and can be accessed from any computer with an Internet connection.

Administrative overhead was also reduced: Now only one set of invoices is managed rather than those from multiple vendors with differing invoice systems and contracts. This allows Millennium personnel to focus their efforts on their core competency, which is the discovery and development of new treatments. Through outsourcing, the company has been able to significantly decrease its staff, freezer size, and real estate. Millennium is fully confident that its samples are safe, secure, and can be accessed quickly when needed.

The Future of Biorepositories

The quantity of biomaterials produced from research and clinical trials continues to grow exponentially. By outsourcing these functions to experts in the field, drug manufacturers can mitigate risks and focus their resources on their core competencies. Strategic outsourcing obviates the need to invest capital and time into the development of specialized facilities and sample management software capable of handling large quantities of samples and associated documentation.

Whether stored onsite, outsourced to expert providers, or both, investments in a comprehensive strategy for archiving biospecimens and clinical trial samples that includes compliant collection and storage, proper tracking, and audit trails can provide significant value to an organization today and in the future.