ANALYSIS & OPINION
In the bank
16 June 2011Tweet
Thermo Fisher Scientific’s Trish Meek discusses the importance of data management within biobanking
In recent years, there has been an explosion in the number of samples generated for research and analysis – largely due to the increased focus on translational medicine and epidemiology. As such, there has been a significant increase and focus on high-quality biospecimens. How those biospecimens are accurately and efficiently managed is now a top concern for researchers who are often charged with managing enormous volumes of both biospecimens and their associated data. Biospecimens serve as the basis for the novel research and development needed for the discovery of tomorrow’s drugs and medical treatments. This has led to the development of extensive biobanks and biorepositories that feed the demand for samples and libraries to be screened by these high-capacity, high-throughput laboratories.
Data management requirements
The function of biobanks is quite diverse and can range from the storage of frozen cell aliquots intended for primary pharmaceutical screening; to tissue biopsies for disease research; to patient DNA samples; to whole population studies containing multiple aliquots of fractionated blood and urine samples. Biobanks need a system that can be easily configured to address their unique and complex sample hierarchy challenges.
Because each sample can be associated with many types of individualised information, such as patient demographics, consent records, and chain of custody, biobanks and biorepositories must ensure proper biospecimen and data management in compliance with Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), 21 CFR Part 11, Health Insurance Portability and Accountability Act (HIPAA) and Internal Review Board (IRB) requirements for data integrity and patient privacy.
Storing all of this information in a central location enables scientists to easily locate samples and, whether they are looking for a tissue biopsy or an aliquot derived from it, access all of the relevant information associated with that sample. To simplify the process, many biorepositories implement the latest instrumentation and automation systems such as Laboratory Information Management Systems (LIMS), helping to improve efficiency and effectiveness of research and development studies.
For dedicated biobanks, effective sample and metadata management is imperative, whereas pharmaceutical companies, often relying on outsourced resources, may focus on the laboratory data and results gleaned from it rather than the actual sample management. Biobanks located within pharmaceutical and biotech organisations have a clear need of both. For all biobanks, the ideal solution is one that is able to effectively manage the biological samples, the patient demographics, consent records, and ultimately all of the data and results at each level of the sample hierarchy. As the number of biospecimens stored in a biobank grows over time, a comprehensive data management system will ensure that the systems are in place to scale up to manage larger volumes and increasingly complex study requirements.
Real life examples
Population studies, like UK Biobank, take samples from volunteers over time to gain a greater understanding of diseases and how they develop. UK Biobank successfully implemented Thermo Scientific Nautilus LIMS to track, store, manage and report on the biological data from over 500,000 participants as part of one of the largest medical research projects conducted. Through using the LIMS, UK Biobank was able to accurately and efficiently identify storing location and linkage information between participants and samples/aliquots. The LIMS also maintained a record of the volume of samples used and the volume remaining, helping to identify the need for replenishment and guide resource access decisions for depleted samples. The LIMS also prevented human-related errors in data transcription, a common challenge with extensive biobanks and biorepositories.
Thermo Scientific Nautilus LIMS was also utilised by The Nord-Trøndelag Health Study (HUNT) Research Center in one of the largest population-based health studies ever performed. The study was initiated to support epidemiological, clinical and preventative medical research, spanning almost 25 years. HUNT represents an integrated family and personal database of approximately 100,000 people from Nord-Trøndelag County, Norway and offers valuable insight into disease status and progression, particularly in relation to quality of life measures such as environment, education and occupation. Nautilus was chosen by HUNT to accommodate for the vast scope of the project, helping to gather, store, manage, track and retrieve material and data securely, while being able to yield real-time, dependable analysis and reports.
The LIMS has proven to be essential to the management of samples and data in biobanks such as HUNT and UK Biobank, but biospecimen management is not only a problem for population biobanks. Academic research and drug development facilities also need strong biospecimen management. The Miami Project to Cure Paralysis, part of University of Miami, Florida, comprises a dedicated team of scientists who are researching neurons with the long-term goal of developing treatment strategies for individuals with spinal cord injury. The University of Miami relies on its LIMS to automate laboratory workflows at their high content screening (HCS) laboratory. The lab selected a LIMS to manage operations, improve the quality of data, minimise manual data entry to avoid transcription error and enhance productivity.
For the lab, a key driver for implementing a LIMS was the chance to reduce turnaround times, improve forward planning and ensure that standard operating procedures (SOPs) would be followed. Prior to their LIMS implementation, this was a time-consuming, manual process. The solution offers data integrity, guaranteed system availability and performance, allowing the laboratory staff to control its data, time and budget. Only with such as solution in place can the team continue to identify and treat novel mechanisms of injury following brain and spinal cord injury and efficiently translate these discoveries to the clinic.
The importance of information exchange
Biobanks will continue to play a critical role in research moving forward. With the continued focus on translational and ultimately personalised medicine, access to biospecimens will be critical for scientists’ success. In the collaborative environment of translational science, a LIMS provides a single solution for study design and execution, making it possible for scientists to translate data into real medical advancements. As biobanks and other life science organizations work together more closely, data management will play a critical role in facilitating the information exchange and collaboration between these groups.
Trish Meek is director of product strategy, life sciences, informatics at Thermo Fisher Scientific