Cancer and personalized medicine are two research areas in which discoveries are accelerating. Supporting research in these fields are biobanks for the storage of tissue samples. The presence of all types of biobanks has increased at such a rate that nearly two-thirds of US biobanks have emerged within the past decade. According to the NIH’s National Human Genome Research Institute, there are approximately 800 biobanks, hosting up to 50 million samples, in the US alone. According to Genetic Engineering & Biotechnology News, more than one billion samples are stored in biobank freezers by researchers in personalized medicine, disease research, drug discovery and population studies across the globe.

For the purposes of this article, IBO focuses on biobanks that are freestanding collections of human tissue samples used for disease research. The biobanking market encompasses several analytical instrument and laboratory product segments, including automated storage systems, consumables and LIMS. Using these products, biobanks are able to address central issues such as sample integrity and tracking of sample location. The growth of the biobanking market is being driven by emerging Asian markets, increased sample volume and new or expanding biobanks.

One of the beneficiaries of the growing biobank market is the automated storage systems market. These systems are designed to address sample integrity and tracking issues by providing an environment with consistent temperature and minimizing the time a sample spends outside of this environment. Hamilton Robotics is a company with a large presence in the biobanking market. In addition to selling software for sample tracking, tube racks and microplate seals for biobanking, Hamilton offers two automated storage freezers for low to high capacity storage, which are the Sample Access Manager and the BiOS system. The BiOS system addresses the growing number of biobanking samples with the ability to store between 250,000 and more than 10 million samples at -80°C. The system continuously monitors frozen samples and accesses them with a robotic arm, which transfers them to a delivery hatch, eliminating the need to manually open freezer doors and expose samples to warmer temperatures. “The sample maintains its temperature range when it’s introduced, stored and processed,” said Matt Hamilton, vice president at Hamilton Storage Technologies.

Sample integrity in biobanking is an area in which advancements have been made, but one about which more is being learned. Preserving the quality of a sample is imperative, especially for rare samples that may need to be used multiple times for different studies. “Our systems maintain the integrity and the value of the sample. Due to the fact that biospecimens are typically one of a kind, the value of that sample can increase over time, especially if the quality is maintained,” said Mr. Hamilton. Hamilton’s automated storage systems house samples in individual compartments that are 2.1 meters in height. “We try to eliminate the unknowns. If you introduce warm samples right next to [cold samples], there is an effect to that.”

Research suggests that biobank storage of tissues at even colder temperatures may be more beneficial to maintaining sample quality. According to Allison Hubel et al.’s article “State of the Art in Preservation of Fluid Biospecimens,” which appeared in Biopreservation and Biobanking in 2011, certain specimens may be preserved for longer periods of time if stored at temperatures close to -200°C. “At this time, we offer products with temperature ranges of 24°C to -80°C,” said Mr. Hamilton. “Knowing that many applications exist outside of those temperature ranges, we plan to expand our product offering to include a wider temperature spectrum.” Mr. Hamilton indicated that more research on maintaining sample viability over several years and thaw cycles is needed.

Tracking of sample location is another aspect of biobanking in which considerable progress has been made. A complete history of a sample, including its freezing time and freeze-thaw cycles, is essential for biobanks in order to provide traceable evidence that its quality has been maintained throughout its lifecycle. Hamilton’s storage systems generate reports to provide information on a sample’s history. “Not only do you control sample temperature, but you have a history of some of the environments [the sample] was exposed to,” explained Mr. Hamilton. “You have a log of how long it was actually out of the system.” The reports also include information on temperature profile and processing.

Biobank market growth is being stimulated by biobanks in Asia. Many Asian countries have recently launched large-scale biobanking projects, including the Fudan University Tissue Bank in China, the TCS Life Sciences Tissue Bank in India and the Narayana Hrudayalaya Tissue Bank and Stem Cell Research Centre in India. “Based purely on the population within [the Asian] market itself, you’re going to have a substantial number of samples available,” explained Mr. Hamilton.

Another segment of the instrument and lab product market benefitting from biobank growth is consumables. Storage tubes are the primary sample container used in tissue biobanking, although slides can be used as well. Micronic offers a range of consumables used by biobanks, including storage tubes, storage racks, caps, tube scanners and readers, tube sorting systems for transferring tubes between tube racks, and capping and decapping products. The company provides different types of storage tubes, including those labeled using 2-D laser-etched codes, barcodes, color or RFID tagging. Although Micronic has provided storage tubes to European labs for more than 25 years, it only began in the past 10 years to offer tubes specifically for the biobanking market as the number of biobanking samples increased.

Advances in storage tubes have helped to improve the tracking of biobank sample location. One way the tubes have evolved is through labeling. Micronic’s 2-D coded tubes have a laser-etched code on the bottom and thus do not require labels, which can wear off. Therefore, they are more apt to resist deterioration and solvents, according to Micronic, and provide more accurate sample tracking, particularly with samples that are accessed frequently. Also, the laser-etched tubes can be scanned, eliminating the need to manually enter samples into a LIMS system, and 96 tube-codes can be read simultaneously. “Implementing coded tubes is (sometimes) the last step to aid in minimizing sample entry error and decreasing time for input,” said Dana Janssen, director of Sales and Marketing at Micronic. To further improve tracking of storage location of larger samples, Micronic recently introduced 6 mL tubes.

Another aspect of tracking for biobanking is ensuring that samples that leave the biobank can be traced. Like Hamilton, Micronic noted the use of biobank samples in different studies. “Some of these samples have been sent all over the world,” she said. “Some are very rare or very valuable. Having control and traceability within one facility or across multiple sites becomes important in terms of chain of custody.”

The durability of storage tubes can also help maintain sample integrity. Storage tubes used in biobanking need to be able to withstand being frozen at -80°C for long periods of time. “Our products are molded, produced and assembled in clean rooms, Class 7,” said Ms. Janssen. “We only use virgin polypropylene in our injection molding runs. This insures the integrity and consistency of the tubes throughout each batch.”

Both new biobanks and biobanks that are expanding their number of samples are fueling demand for sample tubes. “The number of programs, studies and samples are increasing,” explained Ms. Janssen. “The number of facilities, systems and automation opportunities are also increasing. Whether it is a new biobank, or if the biobank is ready to upgrade their sampling system to a 2-D coded system, we see both opportunities more and more frequently.”

Likewise, new markets in Asia and academic users growing their biobanks are adding to the rise in the number of samples. “Our global sister company, Micronic Europe, has been involved in biobanks being set up in the Middle East and Asia,” said Ms. Janssen. She also discussed one reason for the expansion of academic biobanks. “The academic biobank centers have grown in collaboration with affiliated hospitals that are involved in major disease-centered studies and corresponding clinical studies,” Ms. Janssen explained. Micronic works closely with the Rutgers University Cell and DNA Repository.

LIMS is another area essential to biobank operation and to sample integrity and tracking. A LIMS collects, stores, sorts and retrieves information pertaining to samples. For biobanks, STARLIMS provides LIMS software for tracking sample location and archiving and managing sample data throughout a sample’s lifetime. The LIMS also ensures that standard operating procedures are followed throughout sample collection, processing and storage. “The opportunities for LIMS companies globally are centered on supporting growth of individual facilities and helping to create the communication infrastructure that will drive better collaboration between disparate systems and processes,” said Nancy Rourke, STARLIMS senior product manager. “A LIMS, such as STARLIMS, that can ‘connect’ the wealth of information and material that a biorepository holds with the researchers who need those assets will prosper.”

A LIMS needs to accommodate complex sample requests when a particular type of sample is needed for a specific project or study. “The ability to record any and all clinically significant data at the time of sample receipt, and later retrieve information by any parameter associated with the sample or patient, provides both the biobank and its research clients a better degree of confidence in the samples and later results,” explained Ms. Rourke. “The biggest challenge facing all biobanks today is access to the relevant sample data so that the best samples are retrieved for a particular study, which in turn helps the eventual study data to have real meaning to the researchers, and ultimately to the medical community,” she added.