In August 2020, the East Coast of the USA was hit with two crises, SARS-CoV-2 and Hurricane Isaias. The latter was a fast-moving hurricane that raced up the I 95 Biopharm belt on the Eastern USA. Biopharm was in danger from each of these. Some locations lost electric power for several days. Concerned about SARS-CoV-2, some firms restricted access to R&D facilities. Some existing R&D programs were put on indefinite hold while the staff shifted to crash programs to fight SARS-CoV-2.
The value of their samples was potentially astronomical, especially if they were involved with crash COVID-19 vaccine development programs. Stored, frozen samples may have a replacement cost of $100,000 or more. This value contrasts with how samples are stored. All too often it is in a large front-loading refrigerator that lacks security controls and multi-day temperature protection. Should unanticipated problems occur, one would like high confidence in the pedigree of the sample.
For many life science labs, biobanking is a critical infrastructure, that is often neglected until after a crisis. For example, one needs to know about potential freeze-thaw cycles. Should the sample make it to commercialization, scientists will be interested in specifying storage protocols. But in the background, we know that climate change correlates with increasing the frequency of serious storms.
“Big Brother” at the FDA can ask,“ How does this material compare with the material that we licensed back in 19XY?”
With all the interest in vaccines, which are customarily stored at – 80oC, Brooks Life Sciences (Chelmsford, MA) decided to take a different design approach to improve biobanking integrity. Brooks had developed a robotic human interface for a liquid nitrogen (LN2, -195°C) Dewar style freezer of Chart Vario (CV) freezers (MVE-CyroBio, Ball Ground, GA). In contrast to front-door mechanical freezers, the CV design uses liquid nitrogen as a coolant which reduces electricity cost by 99% (8 W) and operating cost by more than 70% at -80°C. Access is from the top, so gravity helps maintain and conserve the coolant. The hold time on the loss of power or coolant is more than 96 hours.
Using the automated sample insertion and retrieval mechanism previously developed for the -196°C LN2 BioStore III Cryo model, Brooks quickly developed the Brooks Life Sciences BioStore ™IIIv -80°C Automated Storage System for vaccine samples. The BioStore uses Brooks Automation sample handling combined with the proven software than is already compliant with CFR 21 part 11. This aids in error tracking when an out of specification result (OSR) is encountered.
The BioStore III starts with an insulated 60-inch diameter stainless steel double wall Dewar that which has an evaporation rate of 12-14 liters of liquid nitrogen (LN2). This gives an isothermal hold time of 96 hours @ -80°C. Brooks then adapted the BioStore top, which is an automated interface between the samples and humans and computers that provide control and permanent event record.
With the BioStore III software controller, access is secure and documented. All order history and system trend data are tracked and available for auditing. The sample is placed in a unique indexed holding place until the user asks for retrieval. Users can request specific cry-boxes based on barcodes or entered data. The system will identify the rack, engage with it, and wait for the user to indicate they are ready to receive it. This ensures the target box and all materials in the same rack are protected from transient warming events. Then the process is repeated in reverse. The 21-CFR-11 qualified time log makes entries for the time of insertion and retrieval, while always tracking trend data for related to LN2 levels and temperature.
In summary, the BioStore III provides a significant improvement in sample storage technology that should set high standards for biobanking 3.0. The longer hold time is particularly important since adverse events seem to be more frequent, and longer to resolve.