January 15, 2012 (Vol. 32, No. 2)
The biobanking market, estimated at $7.88 billion by Visiongain, is poised to expand as researchers continue to migrate toward the use of human tissues and biomaterials for primary research, and pharmaceutical and diagnostic-tool development.
A large and difficult-to-estimate number of facilities, ranging from individual research laboratories to hospitals, academic centers and commercial entities, collect human tissues and biomaterials.
Collection specialization contributes to the industry fragmentation. There are physical or “real” biobanks, virtual biobanks, matchmaking services, tissue banks, and population banks—regional study cohorts composed of biomaterials with associated phenotypic, lifestyle, clinical, genetic, and environmental data.
Visiongain will provide a forum to discuss opportunities and challenges in the biobank industry at its upcoming “Biobanking” conference in London.
“Although there are vast resources available to researchers looking for human tissue samples with which to conduct relevant studies of new drugs, carry out basic research on mechanisms of disease, or identify biomarkers of disease progression or remission, most of these samples are not readily accessible to researchers without time-consuming legwork,” explains Margaret Clotworthy, director of Human Focused Testing.
Virtual biobanks are working to address the accessibility issue. Organizations such as Human Focused Testing and Scotland-based Tissue Solutions do not house samples; they access existing samples from a network of “real” biobanks and organize prospective collections.
“Both public and private repositories have an important role to play and both stand to gain from, and add value to, collaborations with virtual biobanks,” explains Clotworthy. “Researchers rely on tissue repositories to access samples essential to their work. On the other hand, tissue repositories depend on researchers’ requests for their samples to justify their existence, gain grant support if needed, and support their running costs.
“Scientists will go wherever they know that they can obtain quality, ethically sourced tissues, whether it is a public or commercial source. Scientists and tissue banks both benefit from a way to ensure that the scientists’ needs are matched with the repositories’ resources. Virtual biobank networks facilitate this and will only continue to grow in importance and relevance,” concludes Clotworthy.
Ann Cooreman, COO at Tissue Solution, agrees that there are significant advantages in working with a virtual biobank for both researchers and sample providers.
“There is an obvious symbiotic relationship between real and virtual biobanks that will continue to grow. A virtual biobank fills a niche in the market. The potential of fulfilling the request and the likelihood of being able to obtain rare samples is greater than going to a single biobank. Commercial biobanks do not tend to bank unusual samples; hospitals have no particular bias and often bank with fewer commercially sensitive restrictions.”
Tissue Solutions started with four network sites in 2009 and now has close to 60 different collection points spread over different countries.
“Virtual biobanks cannot exist without physical biobanks as they provide the raw material. As consolidators, they can and do provide a great service to the industry as they offer a wealth of experience and knowledge of where specific types of samples are being held and can provide good advice on the feasibility of obtaining certain tissue types.
“Real biobanks benefit from working with virtual biobanks,” continues Cooreman. “For example, hospitals cannot advertise the availability of their patients’ samples even if they only recuperate costs for providing to the research community. As a commercial virtual biobank we can advertise our services for providing access to such samples and help the noncommercial biobanks with the necessary funds to keep their essential resource operating. We also put material transfer agreements in place with our clients, where needed.”
Virtual biobanks ensure ethical sample collection by their sources with the required reviews, approvals, or licenses and make sure that the consenting procedures live up to international standards so that the samples can be used in commercial research.
Academic and other nonprofit entities also desire to maximize the human potential and commercial value of materials and data they hold.
According to Kristin Goldring, biobank facilitator at University College London (UCL), in 2008 UCL recognized the value inherent in its vast range of biospecimen repositories and initiated development of a coordinated biobanking plan. The aim was not only to improve governance around sample and data collection and use, but also to provide infrastructure—centralized contact points to reduce bureaucracy for researchers; web-based, searchable secure databases to increase sample visibility and access; standardized protocols; quality control; and long-term support for sample storage.
“It was challenging to encourage researchers to use the central infrastructure instead of maintaining their own collections,” says Goldring. “The key to the UCL infrastructure is that the biobanks provide a service, and principal investigators retain control over the samples they deposit. The facilities are more cost-effective than setting up individual collections. In addition, well-designed studies with access to samples and physical-storage facilities, supported by integrated informatics, are more attractive to funding bodies than projects that attempt to develop their own independent resources.”
Crucial to developing the centralized infrastructure was identification of a number of projects with varied requirements. There are currently close to 30 ongoing studies using UCL biobanks, and Goldring projects usage will continue to increase as more researchers recognize the ease-of-access and flexibility of the system.
Tissue banks that provide tissues for transplantation can play an important role in biobanking through provision of tissue for research from well-defined donors. In this way, with appropriate consent, both normal tissue and tissue with specific pathologies could be made available for biobanking and research.
John Armitage, director of tissue banking at the University of Bristol, sees much greater awareness among researchers studying human disease and treatments to use human tissue as an invaluable adjunct to inform and guide animal studies.
Bristol Tissue Bank offers tissues for research from two main sources: donors where there is a medical contraindication to transplantation, and tissues that are currently not transplantable, e.g., retina. The Bristol Tissue Bank, which processes tissue from about 1,500 eye donors and 100 heart valve donors annually, strives to maximize the use of unsuitable tissue in line with the consent and wishes of donor families.
“I would hope that, as biobanks become more established, the boundaries between certain types of biobanks and transplant tissue banks will disappear. Close cooperation and collaboration is the key to advancing the exciting opportunities offered by biobanks. I am sure that transplant tissue banks are in a position to support and promote biobanking. It would make sense for Bristol Tissue Bank to move forward into biobanking and this is currently being considered,” Armitage explains.
Over the last 25 years, the Norwegian University of Science and Technology (NTNU) has collected biomaterial samples and associated phenotypic, lifestyle, genetic, clinical, and environmental data from the general population of Norway’s Nord Trøndelag region.
The HUNT Study began in the early 1980s with subsequent studies taking place approximately every 10 years (HUNT 1–3). HUNT 4 is expected to begin in 2015. With a participation rate at 60–88% (30,000 participated in all three current studies), HUNT is a special source for longitudinal studies and allows access to samples drawn prior to disease onset, making early disease biomarker identification and validation possible.
In 2005, the Norwegian government set up strong incentives for increased commercial activity within the country’s public universities and hospitals, and NTNU started a dedicated company for commercialization of the HUNT study. This company, HUNT Biosciences, holds an exclusive, commercial license to the population biobank material.
“Commercialization is challenging within a strong academic scientific environment. In addition to making the internal changes required by industry, such as achieving ISO 9001 certification, the main challenge HUNT Biosciences faced was to figure out how to make the massive amount of population and biobank data accessible.
“Imagine the matrix set up by 130,000 participants, more than 5,500 data variables, and 3.5 million aliquots of biomaterial topped with almost 50,000 genetic analyzes. It was important to visualize the most important cohorts within the data mass and to focus first on drilling that data down,” explains Håkon Haaheim, CBO.
HUNT Biosciences started operations in 2009 and signed its first industrial collaborations in 2010. Product development takes time, still Haaheim is optimistic that the first diagnostic utilizations may hit the market next year and that an existing commercial pharmaceutical product will be released for new indications in 2015.
Dutch Medical Center Adopts Next-Generation Automated Biobanking System
Scientists involved in the LifeLines Study at the University Medical Center (Groningen, The Netherlands) have become one of the first adopters of Hamilton Storage Technologies’ new BiOS system.
“The Netherlands and Northern Europe are at the forefront of biobanking advancements today,” said Martin Frey, Ph.D., senior product manager of storage technologies at Hamilton Bonaduz (Switzerland). “There is a sharp focus on sample quality and these countries are pushing for new levels of standardization.”
This is evidenced by large pan-European projects like the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) and BioSHaRE and Dutch initiatives including String of Pearls, BBMR-NL and LifeLines, he added.
LifeLines is a three-generation population-based study with 165,000 participants from the homogeneous Northern provinces of The Netherlands. The goal is to study universal risk factors, and their modifiers, for multifactorial diseases such as cardiovascular, diabetes, asthma/COPD, and depression.
The project currently stores samples in more than 60 freezers. The samples include urine, plasma, serum, buffy coat, and DNA. Manual sample picking is time-consuming and exposes the stored samples to temperature and moisture fluctuations.
With about three million samples in manual storage freezers and plans to have over eight million by 2017, LifeLines undertook an in-depth public tender process, with a clear focus on sample integrity and risk management. It ultimately chose the BiOS system, which was just introduced last month. Plans call for it to be built to specifications, delivered, and implemented next year, noted Dr. Frey.
According to Marcel Bruinenberg, research lab manager for LifeLines, biobanking is all about long-term storage and the goal is to have viable samples that have been stored for as long as 30 years. Even as recently as ten years ago sample temperatures were not being tracked, he said.
BiOS is Hamilton’s third-generation automated system designed for ultra-low temperature storage of sensitive biological samples. The system was designed to ensure the integrity of 250,000 to more than 10 million sample tubes at temperatures down to -85°C.
“We are finding that scientific journals are now asking for proof that all samples in a study have been tracked and that temperature profiles have been maintained,” explained Dr. Frey.
The solution for LifeLines also incorporates a special system for transporting the samples, using special transfer cassettes and chest freezers, from the central processing laboratory at the University Hospital to the central biorepository, which is about 6 km away, just outside the city.