Biospecimens and the data derived from these materials serve as the framework for effective translational medicine research. When properly preserved, biospecimens represent a significant resource of genetic and genomic information that can be used to develop new drugs, novel biomarkers and personalized molecular diagnostics.
Given the intrinsic value of these materials, preserving the integrity of biospecimens to the highest of standards is critical, not only from an operational and scientific perspective, but also from a regulatory and financial standpoint. As a result, it is important for research companies and organizations to have a profound understanding of best practices in sample management and biorepository operations in order to ensure the long-term preservation of biospecimens for future research.
Best Practices for Sample Management
While standard operating procedures (SOPs) exist within many research organizations for the management of research samples, the most referenced global guidelines are published by the International Society of Biological and Environmental Repositories (ISBER) and the U.S. National Cancer Institute (NCI). Additionally, in 2012, the College of American Pathologists (CAP) developed a gold-standard biorepository accreditation program.
Informed Consent and Pre-Analytic Sample Processing
Planning for sample availability to support future research begins with obtaining the proper patient consent prior to sample collection. In addition, irrespective of sample type, source or the assay being performed by the researcher, it is essential that the unique information associated with each sample be determined prior to collection and documented at time of collection. Research protocols should be explicit regarding consent, collection and processing requirements (i.e., consent form, collection process, centrifuge time, defined temperature requirements and the manner in which the specimen should be processed and shipped). Providing sites with a specific sample management section within their investigator manual can help improve compliance of site processes and reduce the impact of pre-analytical variables on sample integrity prior to laboratory processing.
Sample Bioprocessing Techniques
Sample bioprocessing methods may impact the results or interpretation of research studies. Inefficiencies in sample preparation can lead to sample loss, re-processing or complicated data interpretation, which can slow the process of obtaining conclusive results. As a result, sample preparation and processing requires careful coordination and planning from the outset of the study design to reduce variables that could potentially degrade sample integrity. Recent advancements have been made in the development of assay and genotyping panels which assess the functional quality control of samples enabling improved performance prediction and qualification of sample quality prior to storage and research use.
Good Storage Practice for Long-Term Storage
Good storage practice guidelines require discipline and attention to critical details, such as regulatory and industry compliance, process standardization, data management, logistics and business continuity planning. They should also be integrated into SOPs to ensure processes are widely recognized and constantly met by personnel. All staff that manages samples needs to be trained on these best practices and SOPs should be regularly updated to guarantee compliance to an expanding array of regulatory requirements from a number of entities.
Factors to consider when establishing SOPs for good storage practices include:
- Secure facilities and redundant measures to ensure specimens are kept in compliant conditions at all times when in storage
- Expert staff that has been trained specifically in sample storage and transportation
- Unique sample bar-coding and chain of custody-tracking to support regulatory audits
- Storage technologies capable of monitoring and reporting sample temperature variations and manage inventory that are US FDA 21 CFR Part 11 compliant
- Business continuity plans and redundant systems to protect sample integrity during emergencies
Sample Management Technology Systems
Because pharmaceutical and biotech labs typically implement a wide range of information platforms, sample management software should seamlessly interface with other systems, provide global data integration and access and be highly configurable to easily integrate with a variety of laboratory workflow models. Connecting information on sample storage location, temperature and pre-testing evaluation with the resulting data from a clinical study can enable researchers to improve their selection of samples for biomarker testing while shortening development timelines.
Smartsourcing Sample Management
The growing industry trend towards personalized medicine combined with reductions in research funding has created the need to convert biospecimen collections into sustainable research assets that can be leveraged for future research. In an effort to optimize potentially invaluable research samples and reduce management cost, many research organizations are trending towards a “smartsourcing” approach that moves beyond the traditional “lift and shift” outsourcing philosophy to a more flexible “value by innovating” philosophy.
Various flexible sample management models exist including offsite, onsite and hybrid models. Regardless of which sample management model is selected, research organizations can benefit from developing a comprehensive sample management strategy based on Good Storage Practices.
Today, research organizations are becoming increasingly cognizant of the need to optimize the value of their sample inventories. The application of sample management best practices enables these organizations to deliver improved sample quality, reduce risk of sample loss and create resource efficiencies, which support the research and development of future medical therapies.