Defense In Depth: Off-Site Storage Of Biological Specimens And Biopharmaceuticals For Risk Mitigation

By Bruce C. Simpson

The management of risk is part of all business operations, but to commercial biobanks, clinical research institutes, biotech, and pharmaceutical companies, risk mitigation is 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 off-site 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.