Managing Biological Samples in Today’s Drug Discovery & Development Environment

It is well documented that properly-preserved biological samples, along with their linked clinical data, are valuable assets for the advancement of medical knowledge and the understanding of disease. This has subsequently transformed the way researchers collect, transport and manage samples and their associated data, bringing to the forefront the need for more strategic management of these materials.

A comprehensive sample lifecycle management plan provides detail on where and who will manage samples, as well as what resources will be required. Of equal importance is what processes will be used to manage samples, and what technologies can be leveraged to improve their efficient and timely access. Experience shows while most organizations feel satisfied they have solved the ‘‘who’’ and ‘‘where,’’ the sample management processes and technologies elements are often underdeveloped. A comprehensive sample management program must address all four of these factors. Of course, the development of a good plan requires insight into the long-term strategy of sample use, which can be gathered by conducting a current, desired, and future state analysis of collected samples.

This article highlights how a holistic approach to sample management, with strategic consideration for every stage of the sample lifecycle, can maximize the scientific use of sample inventories.

Comprehensive Lifecycle Sample Management

Lifecycle management plays an important role in extending the utility of research samples. From a process standpoint, it requires a comprehensive plan for the collection, transportation, bioprocessing, protection, retrieval and disposal of research samples. The ultimate goals of a lifecycle approach are minimizing transportation hand-offs (i.e., touches), ensuring optimal and secure storage, utilizing effective cryopreservation to eliminate unnecessary freeze-thaw cycles, and optimizing sample access. This requires a sample management specialist organization that understands the downstream needs of researchers, as well as the overall business impact from improved effectiveness and efficiencies of sample protection and its lifecycle. Sample protection is focused on optimal use of automation, cryopreservation and secure storage of vital sample assets.

Best Practices for Sample Collection and Bioprocessing

Sample Collection

Sample collection involves three components: collection of the sample, bioprocessing of the sample, and recording of information about the sample. It is also during this phase where various pre-analytical variables can be introduced to the sample that can potentially alter testing results. Consequently, even the most “routine” processes should be taken into consideration. For example, blood collection devices are a potential source of pre-analytical error in laboratory testing. Therefore, even the size, quality, fill volume capacity, non-leaching and minimal evaporation characteristics of sample storage tubes are important considerations for the proper selection of the right tube for the right process requirement.

The International Society for Biological and Environmental Repositories (ISBER) has developed best practices recommendations – Standard PREAnalytical Code (SPREC) – that identifies and records the main pre-analytical factors that may have an impact on the integrity of research samples prior to storage. As a golden rule, if pre-analytical variables cannot be controlled, they must be notated for reference at a later time.

Sample Bioprocessing

Sample preparation includes aliquoting, nucleic acid extraction, purification, and downstream processing. Aliquoting of parent samples enables organizations to preserve the initial sample collected while providing the exact amount of sample volumes to the research bench, which reduces the cost of shipping extraneous sample volumes to testing labs and improves preservation of the original parent sample in a single storage location for future research.

New and improved sample functional and analytical quality control techniques now exist that enable researchers to evaluate the ID and quality of the sample prior to storage. This enables improved functional assay development and downstream genomic expression and sequencing of samples. Optimal protocol development ensures the right technology is matched for each application and sample type. Centralization of bioprocessing and sample management within a single location is a new industry best practice trend. The Bioprocessing Solutions Alliance between Rutgers University Cell and DNA Repository (RUCDR) Infinite Biologics and BioStorage Technologies, a subsidiary of Brooks Life Science Systems, is an example of how comprehensive biobanking and bioprocessing services can be centralized at a single location. This approach allows clients to maximize genomic and cell-based research capabilities while improving sample storage that reduces management cost and time expenditures.

Sample Storage – Automated Sample Handling

Manual freezers have long been a mainstay for research labs, and scientist at the bench, but often present limitations and introduce the potential for sample degradation. After samples are collected, they are often retrieved for testing or analysis and re-stored in the freezer. This process of opening and closing freezers doors can actually create temperature variances that can compromise the integrity of the sample. Samples are often stored in racks or boxes of multiple samples and removal of an entire container to secure one or a few samples can jeopardize the remaining innocent samples that are not needed at the time. Furthermore, security and access are also major factors to consider in sample management and storage. Advanced techniques are required for biorepositories handling large quantities or highly-specialized samples. Deficiencies in sample handling protocols and lack of an audit trail could also prove detrimental to the end utility of collected samples. Automated sample management systems can overcome many of these hurdles by providing end-to-end handling and tracking across all aspects of sample management.

Best Practices in the Strategic Outsourcing of Sample Management

Outsourcing sample management services allow companies to eliminate capital and overhead expenses associated with sample management while significantly improving sample accessibility, protection and improve line-of-sight tracking of sample assets. The ability to integrate sample data is essential to successful sample lifecycle management. It is important to find an outsourcing partner with secure, state-of-the-art storage equipment and advanced technology solutions that can unify sample data from multiple research laboratories, CROs or biorepository facilities located in various areas around the world. The improved sample lifecycle management expertise and technology brought to a research organization by an outsourced sample management service provider enables a research organization to focus on their research core competencies and to speed future research advancements to the market.

Due to the financial and scientific importance of collected samples, these materials should not be left to ad hoc processes and disparate technologies that can jeopardize their integrity. Future advancements in personalized medicine which demand increased volume and improved through-put of research samples is driving the need for innovative new strategies in sample management. Now is the time for organizations to establish a comprehensive sample lifecycle management strategy that incorporates and dictates how samples are collected, transported, processed, stored and documented throughout their entire lifecycle. Whether managed onsite, outsourced to expert providers or both, investments in a comprehensive strategy for archiving samples generated during research and discovery can provide significant value and cost-savings to an organization today and in the future.