Are you involved in continuing discussions about the need for finding biomarkers and improving translational research? At the core of biomarker development is the global healthcare movement towards personalized Companion Diagnostics (CDx), in which clinicians and doctors will be able to identify the patients most likely to benefit from a particular drug or biologic, and also help determine risk of an adverse drug reaction from a particular therapeutic agent. While biobanking sits at the heart of biomarker development, the key to quality and sound discoveries is quality management of the biospecimens from the very beginning. From my recent participation in biobanking discussions I’ve heard growing concern over the quality of the biospecimens available and the reliability of research into potential biomarkers.
Collections of biological materials vary tremendously in size, scope, and quality of handling and storage conditions. You understand the need for high quality biospecimen collections for your research, and you may be thinking of building your own biobank. If so, then it is important to ask yourself the right questions. Establishing a biobank takes time, extreme attention to detail, and facility features that may seem like extravagant redundancies. Some obvious, and not-so-obvious, factors to consider are:
1. How much and for how long? Half a million samples sounds like a lot, but a single upright freezer, with the standard 25 ft3 of storage space, can hold 48,000 0.5ml vials. Your sample storage needs may be smaller than you think, and it may not be worth the cost to build.
2. How much does a biorepository cost? You may think a biorepository is “only” storage. In fact, the support systems and personnel requirements are often under-estimated. A reasonable budget for basic construction is $75 to $125 per ft2. Electrical switchgear can run hundreds of thousands of dollars, back-up generators cost about $50,000, temperature monitoring systems start at $50,000, and additional costs for redundant storage units and emergency staffs. Annual operating costs can run between $9 and $17 per ft2.
3. Do you have the time to build? Renovation of warehouse space can take 6 to 18 months for design/approval, permits, construction, equipment, validations, and start-up. Construction from the ground up requires an additional 9 to 18 months.
4. Do you have the team? Do your facility staff members have the time and experience to make the right decisions and guide contractors?
5. What temperatures? Some samples can be stored in mechanical freezers at -20°C or -80°C, while others should be stored in liquid nitrogen.
6. What about risk mitigation? Biorepository facilities require back-up generators, a fuel supply, uninterruptible power supply (UPS) to protect electronics from power surges, temperature monitoring systems, redundant HVAC capacity (mechanical freezers generate a lot of excess heat), a disaster response plan, and on-call staff to respond to alarms after hours.
7. How will you manage your biobank sample inventory and associated data? You may also need a bioprocessing lab that can prepare aliquots, extract buffy coat, DNA/RNA purification, and further downstream sample analysis such as biomarker studies or DNA sequence comparative analysis. A comprehensive Laboratory Inventory Management System (LIMS) that is capable of managing sample inventory and associated sample data annotation is key enabler to translational and biomedical research.
8. What about the support services? Biobanks need dry ice and LN2 suppliers as well as maintenance, calibration, qualification/validation, and repair services for the freezers, refrigerators, temperature monitoring system probes, back-up generators, fire suppression systems, and laboratory equipment.
9. Can you manage the regulatory compliance and QA/QC? Depending on what is stored, biorepositories are subject to regulations issued by the Environmental Protection Agency (EPA), US Department of Transportation (HAZMAT), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), US Department of Agriculture (USDA), as well as state and local agencies.
10. Are you equipped for cold-chain shipping and distribution? Biospecimens must be correctly packaged in qualified shippers and may also need an onboard temperature data logger. Staff must be trained in the regulations mentioned above, and also to work with dry ice and perhaps liquid nitrogen, especially in areas of the world that prohibits the use of dry ice.