As the advent of targeted therapies and personalized medicine becomes a primary component of drug development, the need for high-quality human biological samples has grown in parallel with these advancements in medical science. Utilizing today’s molecular and other analytical technologies, properly preserved samples can be utilized to advance a wide range of medical endeavors, such as:

• Building a deeper understanding of human disease processes and their underlying mechanisms
• Predicting the effectiveness of a potential new medicine
• Identifying possible negative side effects of a potential new drug
• Detecting new biomarkers

Given their intrinsic value, these materials represent research assets that can bring long-term scientific and commercial value to an organization. To this end, researchers from nearly every medical discipline now realize the importance of having a centralized biorepository and a technology infrastructure to store the data associated with each sample. However, many of these institutions face the challenge of transitioning from decentralized sample storage models often with ineffective processes and techniques to more strategic methods of maintaining long-term sample integrity. This approach, where samples are regarded as intellectual property, requires not only a change in management methodology, but also substantial investments in:

• Building specialized, secure facilities with dedicated, scalable storage space
• Purchasing state-of-the-art equipment
• Establishing global sample management systems
• Establishing a sophisticated cold chain logistics infrastructure that spans pickup and delivery, handling, processing and storage at exacting temperatures and conditions
• Hiring skilled personnel with expertise in sample storage, logistics, sample management, quality assurance, operations and clinical laboratory management
• Maintaining staff training, certifications and accreditations
• Validating equipment, technology and processes
• Developing standard operating procedures, maintaining global compliance and business continuity plans 
• Managing global logistics (import/export) associated with sample centralization

Due to the capital needed to develop and manage a centralized biorepository that can meet the rigorous demands necessitated by personalized medicine and biomarker development, many organizations have turned to specialized outsourcing service partners to manage their sample inventories. Outsourcing is an option for organizations that lack the internal capacity or expertise to directly manage these resource intensive, non-core activities. Companies are also outsourcing their sample management operations with increased frequency due to escalating and costly industry regulations regarding audit trails, reporting requirements and chain-of-custody procedures.

To truly maximize margins in a highly competitive and regulated environment, organizations have improved upon the conventional approach to outsourcing research assets and moved toward more innovative “smart outsourcing” strategies. At its core, “smart outsourcing” moves beyond the traditional “lift and shift” philosophy to a more “value by innovating” philosophy. However, the real goal is for organizations to focus on optimizing their core competencies, outsourcing non-core competencies and investing in technology solutions to drive innovation. As such, we will outline various outsourcing strategies for the management of sample inventories, all of which can help drive research efficiencies, mitigate risk and avoid costly bottlenecks that can delay product research and approval.  

Smart Outsourcing: A Flexible Approach To Sample Management
Organizations outsourcing the management of their sample inventories have a number of options when deciding where and how to store their sample collections. As previously stated, outsourcing sample management with an experienced service provider has both financial and operational benefits. Specialized service providers also offer services such as automated sample tracking and reporting; fully verifiable audit trails; bioprocessing solutions such as the extraction of nucleic acid; verification of DNA purity, yield and concentration; and volumetric and normalized aliquoting. These services allow researchers to customize various quantities of samples from a given subset of subjects into the sample-sized and tubes required for testing.

A traditional model for the outsourcing of research samples leverages an experienced offsite biorepository service provider. In this approach, a company will centralize storage of samples in one or a few biorepository locations outside of its research campus that has experienced staff, consistent processes, and a single sample management inventory system. This approach is the most financially advantageous, as it maximizes the economics of scale and expertise of the outsourcing provider.

For organizations that prefer to have their sample assets closer to the bench side, it may be more advantageous to store sample inventories onsite. With this approach, sample inventories are stored at the research location and are dictated by SOPs and data management technology provided by an outsourced provider. This type of “insourcing” allows for consistency in sample tracking, quality processes and management of individual samples across multiple studies on a routine basis. This model provides research companies with onsite control of samples combined with the people, processes, and technology offered by an experienced sample management solutions provider.

This trend is especially advantageous for smaller biotech and pharma companies with smaller sample inventories, where each sample has high intrinsic value. In this scenario, the ability to integrate associated data quickly is essential to successful clinical research and company growth.

Beyond the operational advantages, there are also business drivers that make “smart outsourcing” approaches an attractive option to companies looking to improve their specimen management capabilities. These include:

• Speed — It could take as long as a year to establish a biorepository that can adequately store physical specimens needed to maximize today’s clinical endeavors. Insourcing alleviates this difficulty, as appropriate infrastructure for data management and storage can be developed in a matter of months. 
• Decreased Cost — Sample management “smart outsourcing” models reduce infrastructure cost, thereby decreasing the need for large operations teams to manage/map data, provide governance and build custom query application.
• Scalability — Because large quantities of biological materials are generated during drug R&D, thousands of samples need to be properly stored and tracked throughout clinical trials and beyond. Through innovative outsourcing partnership models, companies gain the ability to move samples offsite seamlessly to add capacity.
• Quality Assurance — By leveraging SOPs already developed and validated by an outsourced partner, risk of specimen degradation through handling and storage techniques can be mitigated. 

An alternative approach is for a research company to leverage a hybrid sample management model in which active research samples being tested are maintained onsite and managed by an outsourced provider. The long-term storage samples are stored offsite at a central biorepository. This approach achieves a higher cost-savings than an onsite model alone, but requires some investment at the research location. Companies that have some level of internal capacity may have options to use this hybrid approach to their strategic advantage. By judiciously selecting which functions are core competencies and should be handled by internal staff and which to outsource, the use of available capacity and capabilities can be optimized.

Sample Management and Tracking
Proper storage, while critical, is one of many factors in a complex equation. An equally important challenge is maintaining control and visibility of large quantities of stored biomaterials so specific samples can be accounted for and located quickly. After all, proper storage is a wasted effort if specific samples cannot be retrieved when they are needed for testing or ongoing development.

The ideal service partner should offer a web-based sample inventory management system that eliminates paper-based tracking and reporting processes through all stages of a sample’s shipping, handling and storage lifecycle. A professional software solution will:

• Track stored samples with pinpoint accuracy
• Offer realtime access to sample inventory data via the Internet
• Allow users to print reports and schedule shipments or deliveries 24 hours a day
• Verify that samples have been handled and stored in optimal conditions from receipt to storage to retrieval
• Provide U.S. 21 CFR Part II-compliant complete electronic audit trails and FDA-compliant reports

Although biological samples have been stored in the past for many reasons, the consistency and quality of sample storage has become more important due to advancements in molecular technologies and research. These specimens may hold the key to understanding disease processes or outcomes and represent invaluable intellectual property. As such, the services that support such progress also need to be held to the same standards of excellence and accountability. Like many aspects of drug development, selecting the most effective sample management “smart outsourcing” strategy and service partner is a complex, strategic proposition. With the growth in targeted therapies and personalized medicine, it is important for research companies to select a biorepository service provider that can provide flexible sample management options to support changing corporate goals and research advancements.

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Kristina Robson, Ph.D., is senior director of Comprehensive Solutions, BioStorage Technologies, Inc. She can be reached at Kristina.robson@biostorage.com.