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Efforts in Biobanking

Opportunities and challenges are both integral to this expanding global industry

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It may be impossible to overstate the explosive need for -- and proliferation of  --  biobanks in the 21st century. Biobanking, the storing of biological samples for research use, is not altogether a new idea. In fact, in the 1920s, British anthropologist Alfred Cort Haddon (1855-1940) traveled the world over to collect samples that are now housed in a repository at the University of Cambridge in England. It was from one of Haddon's samples that modern science was able to sequence the Aboriginal genome (1) in a technological intersection of past and present. 

In this country, biobanks may best be attributed to virologist and pediatrician Lewis Coriell, MD, PhD, (1911-2001). According to the Coriell Institute for Medical Research website, "In 1953, Coriell initiated a campaign to build the first non-profit academic medical research institute in southern New Jersey. Under his guidance, the Institute for Medical Research began research in cancer, human cytogenetics, infectious diseases, and methods to improve cell culture techniques. The history of the Institute's accomplishments included Coriell's foresight in calling for the establishment of a central tissue culture bank and cell registry to certify and maintain cell cultures. It began with a partnership with the National Institutes of Health to create the first standardized cell repository. Today, the Institute is home to the world's most diverse collection of cell lines and DNA samples available to researchers . Coriell's pioneering techniques for characterizing, freezing and storing non-contaminated cell cultures in liquid nitrogen constitute one of the greatest contributions to modern human genetics."

Modern Biobanking
"Today, biobanking is done on many levels ranging from individual researchers collecting and storing samples from a single project to large repositories acting as a hub for many research collections," explained Tatiana Foroud, PhD, the P. Michaell Conneally Professor of Medical and Molecular Genetics at Indiana University. Foroud is also the principal investigator of the National Cell Repository for Alzheimer Disease (NCRAD), an NIH-funded repository for dementia-related studies. Foroud noted that large repositories are typically a more cost-effective way for researchers to store and share their sample collections without having to build their own infrastructure.

Such repositories of biological samples -- including blood and tissue -- allow researchers access to massive numbers of individuals, and are considered a key resource for research that runs the gamut from personalized medicine to the immensity of genomics. As the breadth of medical research continues to expand globally and personalized medicine moves to the forefront of care, banked samples are a foundation for faster development of improved diagnostics and treatment options.

"Biobanks can be structured in a number of different ways. Some are private and for profit; while others, like ours, are not for profit," explained Kelley Faber,MS, CCRC, clinical research manager NCRAD. "Because we are NIH funded, we work on a cost-recovery basis. Therefore, while our repository has not grown in profits over time, it has grown in size."

Faber said the National Cell Repository for Alzheimer Disease has also evolved in tandem with changing industry needs. "Over the past 20 years, the repository has expanded its scope of work to adapt to changes in technology and advances in the field. For example, we initially banked blood that was used to extract DNA and create cell lines, a replenishable souce of DNA. As the amount of DNA required for scientific experiments has decreased, we have been able to use blood samples for purposes other than DNA extraction and cell lines," said Faber.

Foroud added, "Today, we bank a number of different kinds of samples including plasma, serum, RNA and peripheral blood mononuclear cells. There are opportunities for biobanks to focus on particular sample types or to focus on unique services or assays. These are all potential areas of growth that a biobank can use to differentiate itself and create a market."

Expanding Industry
According to a February 2014 report from Dark Daily, opportunities can also be found in the variety of business models - both brick-and-mortar and virtual -- accompanying the growth of the nearly $8 billion biobanking industry.

"Both clinical laboratories and anatomic pathology groups have an opportunity to participate in biobanking activities" according to the report. "At this stage in the market, however, few medical laboratories formally participate in biobanking activities. Experts believe that is likely to change. Researchers and pharmaceutical companies have an enormous need for access to large quantities of human tissue samples, especially if they can be pre-screened for specific disorders and diseases. For example, many research studies would benefit from having access to as many as 2,000 tissue samples from men and women diagnosed with the same type of cancer. The challenge is that few clinical trials or institutions have the depth and breadth of materials to fulfill such requests. However, genomic screening technologies are now inexpensive enough to make biobanking possible."

A Google search of biobanks offers up some revealing headlines -- "AstraZeneca Establishes First Russian Biobank," "Eastern India to Get Its First Biobank," "UK Biobank Open to Researchers." It would seem that even though the number of tissue samples in American biobanks was estimated in a 1999 RAND handbook of human tissue sources to be more than 300 million by 2000 and increasing by 20 million a year, (2)  the greater expansion of the industry is outside of the United States. Dark Daily reported that The Netherlands and Northern Europe have taken the lead, while China is in the process of setting up its own biobank.

So, why doesn't every U.S. lab jump onto the biobanking gravy train -- pronto? First, there are considerations of infrastructure. "The primary challenge a lab should consider before undertaking biobanking is whether or not they have the proper infrastructure in place to support their bank," said Faber. "In order to successfully bank and share samples, a biobank needs the proper lab equipment, staff and a database for tracking samples coming in and going out. In addition, due to the increasing need for large numbers of samples in sequencing projects, researchers are more frequently turning to repositories to centralize efforts. It is much more efficient to go to one location and find samples from multiple projects than to have to ask each investigator individually."

In addition to infrastructure and the money it takes to develop it, a biobank must be highly disciplined to ensure quality and integrity of samples. It must also grapple with the less tangible challenges - such as legal and ethical implications around incidental findings.

Labs interested in attaining a standard of excellence in biobanking can get help through the College of American Pathologists' Biorepository Accreditation Program that debuted in 2012. A look at the 2014 checklist of practices required for accreditation can be viewed on CAP's website .

Valerie Neff Newitt is on staff at ADVANCE. Contact: vnewitt@advanceweb.com.

References:

1. Monya Baker. (2012). Biorepositories: Building better biobanks. Nature. doi:10.1038/486141a

2. Eisman, E. & Haga, S. Handbook of Human Tissue Sources (RAND, 1999).




     

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