Each year, more than 20 million tissue samples are collected and stored in the U.S. for a range of purposes, including basic research, epidemiology studies and clinical trials. These samples are kept in biobanks or biorepositories, facilities that accept, process, store and distribute biospecimens and associated data for use in clinical care, biology and medical research. The scope of data associated with biospecimens has increased tremendously in complexity from basic information, such as date of collection and disease diagnosis, to large information sets including many details about the patient donor and expanding into genetic, proteomic or metabolomics data.
Biobanks, initially developed at universities to support specific research projects, have evolved over the last three decades into complex entities supported by the government and other health and science institutions, or in some instances run as commercial operations. Several international institutions have initiated the development and dissemination of best practices, issuing recommendations for ethical and regulatory practices in biobanking, and for rigorous handling of biospecimens.
The collections held at modern biobanks are professionally designed and maintained to ensure reporting integrity with clinical and genetic data, in addition to preservation of biological activity and properties of the samples. Most biobanks store dried or frozen blood, but more recently, biobanks are increasingly faced with the task of stabilizing complex materials such as eye or brain tissue, as well as living cells and organisms. The protocols employed in sample preparation determine the type of analysis and purpose that the sample can later be used for. The increased precision of medical and biological scientific research has driven a demand for high quality specimens, collected and processed under defined protocols and associated with clinical and laboratory data that are reliable, accurate, and standardized. Therefore, sample preparation, record-keeping, monitoring and security in biobanking are of the utmost importance to researchers to ensure the integrity and reproducibility of their results. This article will focus on three key areas for biobanks: sample collection and processing, sample monitoring and storage, and sample security.
Specimen Collection and Sample Processing
The quality of biospecimens and associated data must be consistent and needs to be collected according to standardized methods in order to prevent artifactual analytical results during downstream research that would lead to erroneous study interpretations. Sample preparation is a critical step prior to storage, requiring planning, rigorous documentation and practices. Without proper specimen handling and organization, biobanks are likely to face unnecessary problems that can limit the usefulness of valuable samples and compromise years of research.
Given current trends in biobanking, it is important to ensure the ability to meet an increasing demand and to support high throughput operations. When planning specimen handling, it is also crucial to consider the processing requirements for downstream procedures once samples are removed from storage. Below are some recommended best practices:
· Use sample collection containers that are secure, traceable and designed for streamlined specimen collection and downstream processing.
· Consider stand-alone sample collection containers and/or custom assembled collection kits to streamline and standardize collection across a range of sites.
· Select high quality disposable products, free of contamination, to maintain integrity, purity and/or sterility of collected samples.
· Ensure consumables and equipment are designed for high throughput when needed.
· Consider the needs for speed and reproducibility when choosing a liquid handling technology required for sample processing.
· Pay attention to the efficiency of the workspace in order to support streamlined sample processing. If maximizing the use of space is an issue, consider benchtop centrifuges that will increase capacity while minimizing the actual footprint. Select biological safety cabinets (BSC) that are reliable and energy-efficient, offering adequate sample protection while featuring ergonomic design.
The organization of samples with a biobank is also crucial to ensuring optimal results and sample protection. Some tips for maximizing efficiency in your biobank's organization include:
· Ensure the use of sample collection containers that are traceable and standardized to guarantee uniformity across collection sites and initiate a robust chain of custody and sample identification.
· Use transportation containers that make possible an organized and secure transfer of samples from collection site to processing location, including maintaining the proper temperature to ensure sample integrity.
Sample Record Keeping and Monitoring
Monitoring both sample condition and biobank stock are critical elements of biobank operations. If the use of samples is under accreditation compliance, the ability to monitor quality parameters of the samples and to keep accurate records is paramount. The recent introduction of tracking technology greatly facilitates this task:
· Availability of consumables with permanent traceable features to enable scanning and tracking from collection to analysis through data management software (for example, containers with 1D- and 2D-barcodes that are part of their permanent construction.)
· Development of a range of sample management systems for accurate and efficient sample tracking and retrieval (for example, sample management software such as Laboratory Information Management Systems (LIMS), designed to assess the quality of samples stored in and retrieved from a biobank, and use of 2D barcodes in combination with barcode readers).
· Access to the latest applicable local, federal or international regulations.
Storage and Sample Security
A biobank must have processes in place to carefully store, secure and document access to all samples, especially if they are rare, need to be cryopreserved or are otherwise labile. Comprehensive protection must include high quality and robust storage tubes that are compatible with relevant storage conditions. Additionally, 24/7 monitoring and detailed event logs to track all biobank activity is essential to ensuring adequate sample security. The use of wireless remote monitoring systems enables biobanks to survey vital equipment such as refrigerators and freezers in real-time throughout the facility. These systems transmit instant notifications of power or mechanical failures, which can be customized. They also feature multiple reporting options available to meet a diversity of needs. Other approaches to ensure sample preservation, include:
· Employment of the latest tube and capping technologies to prevent sample loss and degradation.
· Use of controlled-rate freezers for sample preparation or prior to ultra-low temperature (ULT) storage, featuring multiple freezing profiles and thus enabling strict adherence to different protocols.
· Use of storage equipment that provide for the biological needs of the samples with reliable temperature uniformity, recovery and back-up systems to minimize the risk of sample loss.
· Security systems for samples and associated information.
· Back-up of rare and valuable samples.
· Wireless monitoring for off-site monitoring and regulatory compliance
Biobanks are increasingly becoming an essential and complex resource in biomedical research and medicine, supporting many types of cutting-edge research such as genomics and personalized medicine. The management of biobanks has been rapidly transformed by technological advances like automation, computerization and the use of Web-based platforms. In order to provide biospecimens of high quality and associated with well-characterized, reliable data, biobank operations must adhere to the use technical best practices. Evidence-based standard operation procedures are actively being developed to document requirements and recommendations for sample collection, processing, storage, quality control and data management, aiming to provide robust quality standards in biobanking.
Kiara Biagioni is product manager, storage tracking at Thermo Fisher Scientific, and Alex Esmon is global product manager, cryopreservation at Thermo Fisher Scientific.