If your organization needs a biobank, one of the first issues you must tackle is this:
Where and how will you store the biospecimens? Is it essential for you to build your own biorepository or can you outsource your biobanking needs?
The answers to those questions are usually quite complex, and they vary from organization to organization. After all, each research project has its own unique goals, and collections of biological materials can differ tremendously in size, scope, handling constraints and storage requirements.
Are you debating whether or not to build your own biobank? If so, here are the key pros and cons to consider:
- Control. When you build your own biobank, your organization has complete control over all the parameters of collection, handling and storage of the biosamples. You’ll also be better able to control proprietary information, your response to problems, expenses and compliance. (In terms of compliance, remember that, 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.)
- Access. An on-site biobank makes access to your biosamples easier and quicker.
- Build-to-suit. Your biobank can be built to your specific research parameters. You’ll need to consider everything from mechanical freezers and/or LN2 storage to laboratory information management systems (LIMS) and duration of storage.
- Adaptability. When you run your own biobank, you can adjust collection, handling and storage conditions as your research needs evolve.
- Time. Establishing a biobank takes time and extreme attention to detail. Renovation of warehouse space can take six to 18 months for design/approval, permits, construction, equipment, validations and start-up. Construction from the ground up requires an additional nine to 18 months.
- Expense. Don’t make the mistake of thinking a biorepository is “just” storage. In fact, you’ll also need to budget for support systems and personnel. For instance, basic construction typically runs about $75 to $125 per sq. ft., but you’ll have to add on electrical switchgear (hundreds of thousands of dollars), back-up generators (another $50,000), temperature monitoring systems (which start at $50,000) and additional costs for redundant storage units and emergency services. Annual operating costs can run between $9 and $17 per sq. ft.
- Personnel. Carefully assess current members of your team. Are they qualified to guide contractors? How many additional personnel will be required to maintain the biobank once it’s built?
- Expediency. Finding a biobank to outsource your biobanking needs won’t be nearly as time-consuming as building –and then running –your own biorepository. How will the delays associated with building your own biobank impact your research?
- Costs. Hearing your need to store “half a million samples” might give you pause, but a few quick calculations can help you regain perspective. For example, a single upright freezer with the standard 25 cubic ft. 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 cost-effective to build.
- Minimal additional personnel. You’ll need staff to manage the outsourcing contract, but in general terms, outsourcing will require fewer personnel than building your own biobank.
- Short-term storage. If your biosamples only need to be stored for a few months, it may not be worthwhile to build your own facility.
- Risk mitigation. Outsourcing reduces risk headaches. 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.
- Control. Outsourcing your biobanking needs requires relinquishing some control over how biosamples are collected, handled and stored. Does your outsourcing partner meet your requirements for quality management, privacy, compliance, risk mitigation, etc.?
- Access. When you outsource your biobanking needs, the logistics of accessing your samples may be complicated and somewhat time-consuming.
- Not built-to-suit. You’ll have to adapt your research to the biobank’s existing capabilities –or devote time and effort to negotiate changes.
Deciding whether or not to build your own biorepository is a complex process that demands thoughtful and informed deliberation. Are you currently debating the pros and cons? Which factors weigh the most in your decision-making?