August 26, 2021
The study of diseases has greatly evolved over the years as more information can be collected from samples obtained from groups comprising tens, hundreds, or even thousands of subjects. Body fluids or tissues (such as blood or biopsies) can be collected from these donors along with other information such as demographic information and medical history. Thus, there is a need for repositories such as biobanks that can store and manage samples derived from patients as well as healthy donors.
Biobanks are repositories that store biological samples and associated metadata for human research. The process of collecting, storing, and maintaining these samples obtained from patients and healthy donors is known as biobanking. Samples may need to be stored securely for several years for present and future research. Establishing a biobank requires careful control of various steps such as sample collection, processing, storage, and transportation. Therefore, preserving sample quality and integrity is essential, which necessitates rigorous quality control within a biobank to meet present and future needs.
Samples may be required to be used several times, either for a specific study or entirely different projects. Before using a sample, it has to be taken out of freezers and thawed before use. However, repeated freeze-thaw cycles might degrade sample quality and consequently deteriorate the outcome of the research. Thus, the same sample must not be subjected to multiple freeze-thaw cycles. A solution for this is to fractionate samples in small volumes for single use. In this way, a fraction can be used for specific research, while the remaining sample can remain in storage until needed. Consequently, biobanks are required to maintain a log of the number and quantity of samples and aliquots available and record any freeze-thaw cycles.
Adequate storage at temperatures below –80 ºC is essential to maintain sample integrity. Ultra-low temperature freezers are used to store samples for several months. For long-term preservation, lower temperatures (< –150 ºC) are needed; thus, containers with vapor-phase liquid nitrogen must be employed. Samples can be stored in liquid nitrogen for years, but the containers must be routinely checked. Records of maintenance services indicating when nitrogen tanks were refilled or if there were any malfunctions should be maintained.
To maintain the integrity of biological samples, they should be frozen and recovered using automated systems. Manual systems are usually labor-intensive, which makes them prone to human errors. Moreover, fluctuations in temperature can have detrimental effects on biological samples. When storing a large number of samples, the use of heat-sealed tubes provides better storage because they offer easier handling and high sample integrity at low temperatures than screw caps. There are automated systems that can uniformly seal these tubes, eliminating errors arising from manual screwing. Additionally, proper labeling of samples is essential for their seamless tracking.
A biobanking LIMS, also known as a biospecimen management system, helps biobanks securely manage all the required sample information to facilitate research. It tracks freeze-thaw cycles, maintains a record of the storage temperature of each sample, and generates custom sample and storage reports. It also helps manage donor data, consent and anonymizes protected health information of donors to safeguard their privacy. It helps locate stored samples, generates sample labels, and ensures sample integrity by standardizing biobanking workflows.
A biospecimen management system can be integrated with temperature monitoring systems to monitor the temperature inside and outside freezers. Furthermore, it raises an alarm if the storage temperature falls below the optimal temperature. A LIMS also helps follow biobanking regulatory guidelines and best practices, such as ISO 20387:2018, EU GDPR, HIPAA, 21 CFR Part 11, ISBER, and NCI Best Practices.
The emerging demand for personalized medicine creates a need to collect more and more samples and gather specific data. Biobanks are responsible for managing a large amount of annotated sample data and for providing high-quality samples to researchers for clinical trials, cohort studies, drug discovery, and research on life-threatening diseases, such as cancer and heart diseases. Biobanks face numerous operational, data management, and regulatory challenges on a daily basis. A biospecimen management system helps maintain sample quality by managing the complete history of each sample from accessioning to disposal. It enhances operational efficiency and enables biobanks to follow sample management best practices. It also helps biobanks follow regulatory guidelines with ease, automate workflows, eliminate data silos, ensure data security and sample integrity.