For decades, biomaterials such as tissues, blood, and serum derived from clinical testing have played a critical role in drug development and academic research. The recent focus on molecular-based therapies, genomics, and biomarker discovery in today's medical research have dramatically transformed the way biotechnology and pharmaceutical organizations collect, transport, and store their biospecimens.

As the pharmaceutical industry shifts toward a more personalized approach to medicine, the need for high-quality, well-maintained biospecimens is at the forefront of medical research. But despite sophisticated protocols and strict regulations, organizations often overlook developing a strategy for long-term handling and storage of biological samples.

Such a lack of strategy could be detrimental because today's high-throughput molecular technologies allow researchers to implement a wide range of analyses on archived biospecimens that would not have been possible 20 (or even 10) years ago. These analyses have led to a better understanding of genetic and molecular changes involved in the progression of several complex diseases.

For example, advances in molecular and genetic epidemiology have enhanced the possibility of identifying individuals with genetic risk for certain cancers. Furthermore, the use of biomarkers is rapidly advancing, with applications now helping to advance studies in cancer etiology, detection, treatment, and prognosis. The validity of results from biomarker studies using archived specimens, however, depends on the integrity of the specimens and the manner in which they are collected, processed, and stored.

For all those reasons, it is paramount that samples be maintained in the best possible condition and that a history of the samples' storage is kept in the greatest possible detail. For example, plasma samples should be stored at –70 °C to –80 °C with no freeze–thaw cycles (because they can damage sample integrity).

Given the pivotal role these materials play in pharmaceutical product development, long-term storage and handling of biomaterials is becoming an increasingly critical and strategic component of the worldwide drug development process. As such, companies must have detailed business strategies when governing transportation, handling, and long-term storage of biosamples.

Organizations that explore biobanking solutions today have a number of options to choose from including storing on-site, off-site, or both. Nevertheless, due to the capital investment required to build a world-class biorepository, many pharmaceutical and biotechnology companies are increasingly outsourcing their sample management function to expert service providers.

A Case for Outsourcing

To maximize margins and efficiency in a highly competitive and regulated environment, an increased number of biopharmaceutical companies are turning to specialized outsourcing providers to manage resource-intensive, noncore functions. Biomaterial storage, management, and logistics fall directly into this category. These services are particularly well-suited for outsourcing because of their required capital investments in equipment, facilities, trained personnel, technology, security, and transportation infrastructure.

A Biomaterial Storage Provider

Biomaterials generated during pharmaceutical R&D processes continue to grow exponentially in volume, type, and complexity. Even during the storage phase, clinical trial specimens represent substantial market value. For instance, pharmaceutical and biotech companies regularly conduct a range of testing, auditing, validation, and qualification processes on stored samples for different reasons.

Although of major importance, compliant storage is just one of many factors to take into consideration when considering an outsourced partner to manage your precious biomaterials. Because biotech drugs are made out of living cell cultures instead of the simple molecules used to create traditional pharmaceuticals, much of this development (as well as other research initiatives) relies on the safe, on-time, and compliant shipping of biomaterials.

Cold-Chain Management, Tracking, and Monitoring

As clinical research continues its migration toward globalization — expanding to such regions as Latin America, Eastern Europe, and East Asia — the process of transporting human clinical trial samples has become increasingly complex. As a result, the biomaterial cold chain has also become as critical as any other element in safeguarding valuable specimens throughout their lifecycles.

Cold chain management defines how temperature-sensitive products and biomaterials such as clinical trial samples, active pharmaceutical ingredients, and microbiological and viral samples are packaged, transported, and stored throughout research and development. Weakness or failure at any point in the cold chain can compromise product integrity, breach security, delay shipments, and ultimately result in financial loss or liability.

BIOREPOSITORY COSTS