The management of risk is part of all business operations, but to biotech companies manufacturing cell-based therapies, risk mitigation is necessarily a critical element of day-to-day operations. The costly nature of irreplaceable samples/cell lines and high value products such as cell-based drugs, and biological active pharmaceutical ingredient (Bio-API) dictates planning for the full continuum of risk. The best solution is frequently offsite storage.
Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infra-structure in place, beginning with a realistic threat assessment for the location. Download the eBook version here.
Threat Assessments evaluate the probability of such events as:
Risk/threat assessments are necessarily somewhat subjective. Most threats are of a low probability; years of mild weather is normal, and terrorism may be of minor concern as well, except for sites that are near potential targets, such as government buildings and major airports.
In addition to assessing the probability of a threat, the potential severity should be considered. A hurricane may be unlikely, but could leave serious damage behind, including extended power outages.
If an offsite storage provider has not performed a realistic, well-researched threat assessment, then the risk mitigation strategy is based on guesswork.
The Emergency Action Plan (EAP)
Ask potential off-site storage providers if an EAP is in force. Is there a plan for ensuring the safety of the employees, for securing the facility, for addressing the media, and notifying the relevant authorities following a disaster? Is there a plan for restoring normal operations as quickly as possible?
These plans should be written, reviewed at regular intervals in case changes are warranted, tested via walk-through or table-top exercises to the extent possible, and the employees trained on the procedures. Ideally, this training is also documented, reviewed, and repeated annually as well as whenever changes are made.
The plan may include a pre-arranged place for management to meet in the event of a disaster, which is equipped with items such as a battery-operated radio, walkie-talkies, and copies of the EAP. The EAP shoul also list sources for the resources needed to conduct critical business activities:
Location, Location, Location
On the West Coast, proximity to the fault and compliance with local building code is a key consideration. Choosing an off-site storage facility may involve close examination of whether or not the facility is constructed not only to meet minimum code requirements, but to provide the specific protection needed for your valuable materials under worst case scenario conditions.
On the East Coast, is the location susceptible to tornadoes, hurricanes, or severe snowfall? How well does the offsite storage provider prepare for such events? Is the facility prepared for the once-every-fifty-years event as well as the more normal level of severity?
Risk Mitigation Infrastructure
Biological material storage facilities should have back-up capacity well in excess of the minimum requirements. For instance, this may mean 100 percent redundant HVAC capacity. Mechanical freezers expel large amounts of heat that must be removed to keep the units running efficiently, reliably, and for a maximum lifespan. Fully redundant HVAC allows one unit to maintain correct facility temperatures while the other is serviced or repaired as well as provide extra cooling capacity for summer heat waves.
The same is true of back-up generators and their fuel supply. If the bulk tank holds only enough fuel for 72 hours, is there a possibility that the supplier, following a disaster, will not be able to reach the facility within that time frame? Do the back-up generators support the temperature monitoring systems, security systems, the telephones, and HVAC system? An uninterruptible power supply (UPS) should be installed parallel to the back-up generators to prevent damage to electronics during power surges.
Biorepository Building Design
Is the offsite storage building designed to protect against wind and water? Will the roof withstand the weight of a severe snowfall? Are the lower levels protected from flooding? The design should prevent water from entering the facility as well as minimize damage to the power distribution and back-up generators. A number of repository disasters occurred in the wake of Tropical Storm Sandy in 2012; these were in facilities where the electrical switchgear and generators (and in some cases, the biospecimens and laboratory animals) were located in basements that were prone to flooding.
Protect Your Data
The offsite storage provider should manage your inventory data as carefully as your specimens, including back-up of the data on a preset schedule, testing the data for recoverability, and storing it at an offsite, fireproof, well protected location.
Defense in Depth
Risk mitigation occurs at all levels of operations. Additional options include dividing inventory into mirrored collections and storing them in multiple geographically separate off-site facilities.
The question of risk mitigation is never fully answered. The nature of the biotech industry is one of constant change, and we must keep asking: If a disaster happens, will your research and materials be safe?