Biotech: 5 Operational Challenges for Biobanks

The biobanking industry has become a critical pillar for the advancement of the life sciences and clinical research. Biobanks are safe harbors for massive collections of biological specimens, from cancer patient biopsies to environmental samples, making them a staple of ongoing research projects in academia and industry.

Initially, the job of biobanks was simple: Collect and manage samples and dispense them reliably to customers. However, “Biobanking 3.0” has shifted this focus from quantity to sample and data quality assurance, generating value for donors, funders, and scientists. Therefore, current and new biobanks are required to raise the bar on their capabilities to create the highest quality biospecimens and provide their customers with the best experience possible.

This creates some new sample and data management challenges for many biobanking organizations. In the following blog, we look at these challenges and how they can be solved through digitalization.

Challenge #1: Managing Quantity?

In a survey of U.S.-based biobanks, nearly 50% of organizations had over 5,000 samples, and 23% had over 100,000. Tracking the location of these large sample collections is a major issue, and having reliable processes for labeling or barcoding these samples and documenting their storage position is critical to keeping organized operations.?

In addition, numerous biobanks house a variety of biospecimens encompassing diverse cell types and subtypes. Handling a primary cell type can result in subsequent storage of passages, immortalized cells, or engineered cell variants, with DNA, RNA, or protein extracted at various points in this process. Each specimen type entails distinct documentation, names, identifiers, or properties that must be consistently linked to the biospecimen. The variability across sample types poses a challenge in identifying the specific properties required for each sample. In the case of human samples, it is imperative to store informed consent records and intended use information alongside the specimens to ensure adherence to ethical and regulatory standards.?

Finally, it’s been suggested that 10% and 50% of tumor biospecimens in biobanks will never be used. Continued collection of biospecimens in already large biobanks can lead to additional capital costs for storage and complications managing large and unruly collections. Efficiently tracking frequently and infrequently used samples is essential for making decisions about new cold storage purchases, effective use of space, and lab sustainability.

Challenge #2: Maintaining Sample Integrity and Quality

The ongoing activities of large biobanks involve a continuous influx of new samples being deposited and fulfilling sample requests. The quality and integrity of numerous biospecimens are highly dependent on the storage temperature. Consequently, the repeated occurrence of freeze-thaw cycles, stemming from disorganized sample management where time is consumed in locating and verifying samples, can compromise their integrity. When a biobank possesses limited aliquots of a specific sample, freeze-thaw cycles may become an unavoidable aspect of the sample lifecycle. Effectively managing location data for all biological samples, overseeing freezer temperatures, and meticulously tracking the freeze-thaw cycles of samples are crucial tasks – albeit significant challenges – essential for ensuring sample quality.

With an increased focus on reproducibility in the life sciences, there is also an increased need to report standardized details for biospecimens used in published papers. These details can help ensure that high-quality samples are being used in published studies, thus helping to ensure reproducibility for any subsequent studies. While no agreed-upon relevant dataset exists, guidelines like the Biospecimen Reporting for Improved Study Quality (BRISQ) have been published to improve reproducibility in papers using biospecimens from various sources, including biobanks.?

Challenge #3: Ensuring Data Security

Numerous regulatory mandates and guidelines intricately shape the operational landscape of biobanking. Specifically, 21 CFR Part 11 outlines precise regulations governing electronic data management to uphold data security. Additionally, prominent regulations such as the Health Insurance Portability and Accountability Act (HIPAA), ISO 20387:2018, and others set forth standards for maintaining data security and quality.?

Effectively navigating the entire lifecycle of this data presents logistical challenges. Adhering to the aforementioned regulatory standards requires implementing cybersecurity measures to safeguard data against unauthorized access, ensuring comprehensive traceability for auditability, and meticulously documenting any alterations made to the data.

Challenge #4: Disaster Preparedness

Disaster preparedness poses a formidable challenge for biobanks due to the inherent vulnerability of the biospecimens they manage. The day-to-day operations of biobanks involve meticulous storage and preservation of a diverse range of biospecimens, each with distinct temperature and environmental requirements. Natural, human, or technological disasters can disrupt the controlled storage conditions, compromising the integrity and viability of these valuable samples.?

Ensuring the continuity of operations in the face of unforeseen events demands comprehensive disaster preparedness planning based on an adequate risk assessment. This includes developing resilient infrastructure, implementing redundant systems, and formulating robust contingency plans to mitigate risks and minimize potential losses. Additionally, coordinating efforts to safely relocate and secure samples during emergencies requires precise logistical execution, further adding to the complexity of disaster preparedness in biobanking.

Challenge #5: Planning for the Future

There has been a noticeable surge in prioritizing strategic planning to navigate the growth and expansiveness of both public and private biobanking sectors. Future planning can enable biobanks to make astute and well-informed decisions regarding their future initiatives, including targeted investments in capital equipment like new -20 or -80 freezers or liquid nitrogen storage, precisely timed to meet actual requirements. The persistent challenge for biobanks remains the adept monitoring of ongoing operations and the projection of future demands. Consequently, data collection and analysis to make an informed and strategic purchasing decision is time-intensive, particularly when done manually.

Solving Biobanking Challenges with Better Information Storage Platforms

Many of the challenges above can be solved with user-friendly software platforms with sample and data management capabilities, alleviating the need for manual sample tracking or data collection and analysis.?

However, choosing the right software platform for your biobanking operations can be a challenging task in and of itself. To help you tackle the challenges discussed above (and others) and zero in on which software is best for your organization, read our white paper, “How to Choose the Best Digital Platform for Your Biobank.”

Otherwise, feel free to reach out to me directly!

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