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Dec 1 2008 (Vol. 28, No. 21)
Update on Emerging Biobanking Practices
Companies Need to Safeguard Their Resources by = Setting Up=20 Efficient Storage Systems
Catherine Shaffer
|
Biotech and pharmaceutical companies are not yet fully = comfortable=20 thinking of biological samples as assets. However, new biomarker = discovery=20 initiatives as well as large-scale genome projects and disease = consortia=20 have encouraged the biobank movement, forcing the rapidly changing = industry to think hard about what it will be doing with its = samples in=20 five, ten, twenty, or one hundred years. So now it=E2=80=99s time = to really answer=20 the questions of where and how to store the samples. Researchers from around the globe recently convened in = Philadelphia to=20 share information about emerging biobanking practices. Having a = consensus=20 on the importance of maintaining such banks, = =E2=80=9CBiorepositories 2008=E2=80=9D=20 attendees engaged in a lively discussion about sample collection = and=20 storage on a practical level. It was made clear that storing dubiously labeled samples in = dubiously=20 maintained -20=C2=BA or -70=C2=BAC freezers may not be the most = effective storage=20 choice. These days, researchers looking for biobanking solutions = have a=20 number of sophisticated systems and solutions to choose from. = It=E2=80=99s an=20 exciting time to be setting up a biorepository, because the time = scales=20 are literally as large as your imagination. Samples collected and = stored=20 today may lead to scientific discoveries generations later. There are many ways to establish a biorepository. One angle of = attack=20 is for companies to set up their own, on-site sample-storage = systems. This=20 is happening at companies that already have millions of samples, = as well=20 as companies that are just getting started and may only have a = single=20 freezer. Eric Koenig, senior manager of molecular technologies at IT solutions are absolutely crucial for any SMS, said Koenig. = It would=20 be absolutely disastrous if a key sample could literally not be = found=20 within a repository of millions. IT tools including bar-code = systems and=20 robotic sample handling help to minimize errors in record keeping, = as well=20 as minimize human handling that could compromise the sample = integrity.=20 =E2=80=9CThe whole point of this is to integrate traceability = for all of your=20 samples. If they are well-tracked and annotated, they are usable = and=20 reusable resources,=E2=80=9D Koenig explained. A sample that is lost in storage (either because it is = corrupted or=20 because it literally can=E2=80=99t be found) is a tangible loss to = the company.=20 This is why some companies are choosing to outsource their sample = storage.=20 Samples can be stored at the company site or off site. Most = researchers,=20 however, prefer to keep their samples = close. |
Validation Systems Vital
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Biostorage Technologies will set up a = freezer-based=20 storage system at the client site, and then monitor it for them. = Freezers=20 are a common fixture in industry and academic laboratories, but = for most=20 researchers freezer storage is an out-of-sight, out-of-mind = situation.=20 They don=E2=80=99t think about the validation process required for = long-term=20 storage of their precious samples. =E2=80=9COne of the first things that companies should discuss = is implementing=20 protocols and standard operating procedures to ensure validated = systems=20 are in place,=E2=80=9D pointed out Jennifer Benner, manager of = quality systems for=20 Biostorage. =E2=80=9CThis includes shipping containers, storage = units, and=20 monitoring systems. The FDA requires that companies maintain = documented=20 evidence that provides a high degree of assurance that a specific = process=20 is going to give you the same results. This means that the freezer = is the=20 correct temperature within certain tolerable limits, and that = every=20 location inside the freezer is the correct temperature within = tolerable=20 limits.=E2=80=9D Biostorage Technologies provides temperature-monitoring devices = that=20 ensure that the temperature has been maintained in a container = through its=20 entire chain of custody, from laboratory to a dry ice container = for=20 shipping, to its final resting place (the biorepository). Many of Biostorage Technologies=E2=80=99 clients are working in = FDA-regulated=20 environments, but regulatory oversight is something that smaller = research=20 laboratories aren=E2=80=99t always accustomed to thinking about. = =E2=80=9CI think the=20 industry is about to turn the corner and realize that the FDA and = other=20 regulatory environments are a lot more interested in storage than = they=20 used to be,=E2=80=9D added Benner. |
Liquid Nitrogen Cooling
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Steve Deal, associate director for U.S. commercial operations =
for =E2=80=9CWhen someone opens the door of an upright freezer = commonly seen in=20 hospital and pharma laboratories, the first thing that happens is = the=20 -80=C2=BAC temperature falls out into the warmer area, and samples = are exposed=20 to warmer temperatures that have a potentially negative impact on = the=20 samples,=E2=80=9D said Deal. =E2=80=9CWith sample integrity in = mind, TAP developed a=20 patented drawer-access system that utilizes individually sealed = drawers=20 rather than a single large-door design. Thus, only a single drawer = needs=20 to be open at any time in order to pick or place = samples.=E2=80=9D TAP=E2=80=99s flagship system is based on liquid nitrogen = cooling, not=20 mechanical cooling. This has a number of advantages. One is that = it=E2=80=99s=20 possible to achieve a true -80=C2=BAC temperature. Mechanical = cooling systems=20 generally either fall short or are working hard to get that cold. = Another=20 advantage is that energy usage is actually lower, which reduces = cost and=20 is a more environmentally friendly solution. Mechanical refrigeration is still available from TAP, if that = suits the=20 customer=E2=80=99s needs better, but the liquid nitrogen system = represents its=20 most cutting-edge technology, and from a long-term perspective is = less=20 likely to become outdated. A completely different take on biostorage comes from For many years, the state of the art for biobanking has been=20 cryostorage. But considerations of cost, energy usage, and = standardization=20 led GenVault to think outside the box and tackle dry = room-temperature=20 storage. Dry room-temperature storage of samples is a practice dating = back to=20 the discovery of DNA itself. Rosalind Franklin and Maurice = Wilkins,=20 codiscoverers of the structure of DNA, used dry room-temperature = handling=20 techniques, which improved the resolution of their images the more = the=20 humidity was reduced. DNA is surprisingly stable when stored this way, and, according = to Dr.=20 Wellis, GenVault has updated the method for the twenty-first = century for a=20 simple and energy-efficient small- to large-scale biobanking = strategy. It=20 also has a new chemical matrix, Gentegra, launched in September of = 2008,=20 to stabilize purified DNA and, soon, RNA molecules for room = temperature=20 storage. GenVault=E2=80=99s technology has attracted interest from =
institutions such as=20
the CDC and the =
GenVault also includes a molecular bar code, Gencode, to = augment a=20 conventional bar code based sample-management system. Gencode is a = series=20 of unique oligonucleotides that travels with the sample, and can = be=20 checked independently of other sample ID information. Human error = is a=20 major source of error and information loss in sample management, = largely=20 unacknowledged by science but critical for law enforcement and = diagnostic=20 applications. =E2=80=9CWe cannot yet replace all types of freezer-based = sample storage,=E2=80=9D said=20 Dr. Wellis. But, for those types of samples that work well at room = temperature=E2=80=94they can happily coexist, enhance, and back-up = traditional=20 freezers for a mixed-phase biobank.=E2=80=9D The establishment of a biorepository is a bet that there will = be better=20 uses for your samples in the future, and better ways to extract = that=20 information. There are already many examples of the value of = biobanking,=20 such as the discovery of Gleevec through the exploitation of = Novartis=E2=80=99=20 biorepository. In addition, many of the technologies for analysis = of=20 samples are advancing at an incredibly rapid rate. Whereas in the = past,=20 sequencing of a large number of samples was inconceivable, now=20 next-generation sequencing technologies are bringing that dream = closer to=20 reality. |
Single-Molecule Sequencing
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Patrice Milos, Ph.D., vp and CSO of Helicos has a single-molecule sequencing technology that does = not=20 require amplification or other handling methods that introduce = bias.=20 Technologies such as these bring to the realm of possibility = studies that=20 in the recent past would have been wildly ambitious, Dr. Milos = added. In one example provided by Dr. Milos to demonstrate the = importance of=20 sequence information, it was possible to zero in on a novel gene = variant=20 of cytochrome P450 2D6 in a drug metabolism study by going back to = the=20 original DNA sample and sequencing it. An individual had a drug = response=20 that could not be accounted for using known variables, and because = the=20 company had an archive and access to new sequencing technology, it = was=20 possible to characterize this previously unknown genotype. =E2=80=9CBiorepositories provide a critical component in = addressing the=20 challenges of discovering and developing new medicines,=E2=80=9D = Dr. Milos=20 concluded. |
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