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Sep 15, 2011 (Vol. 31, No. 16)

Sample Integrity in Biobanking

Tips and Tricks to Optimize Preservation and Monitor Biorepository Specimen Handling

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    Bayer HealthCare has a centralized repository where biological samples from animals, disease models, patients, and healthy individuals are housed.

    The need to preserve biological material—whether as a reference archive, a repository for future research, for potential therapeutic use, or as the basis of ongoing drug discovery or production—seems to be growing at an exponential pace.

    From the collection and storage of umbilical cord blood to preservation of transgenic mouse tails, researchers and clinicians alike are constantly faced with challenges of conflicting, confusing, and ever-changing regulatory oversight, expensive cold storage chain logistics, demanding colleagues, unreliable data collection, and unidentifiable samples.

    Yet with challenges come innovations—many of which were discussed at the “World Biobanking Summit,” held as part of the inaugural “European Laboratory Automation” conference.

    Identification and validation of targets, identification of drug compounds, and identification and development of biomarkers are all done on biobanked tissue, said Antje Stratmann, Ph.D., global biomarker research at Bayer HealthCare.

    The company has a centralized repository where biological samples from animals, disease models, patients, and healthy individuals are housed.

    The biobank acts like a bank safe, with a constant supply of samples being deposited and withdrawn. It provides high-quality samples and their associated comprehensive clinical dataset for bioanalytics, both internally and to Bayer’s international network of collaborators.

    This all has to be under strict compliance with legal, ethical, biosafety, biotechnology, standard operating procedures (SOPs), data privacy, and IT guidelines, Dr. Stratmann noted. “And the centralization insures best practice and, in particular, compliance.

    “It makes no sense for each project leader to take responsibility on his own to get this tissue, because you also need the clinical network.”

    To assure that the best use is made of the centrally banked tissue, Bayer has instituted a three-tiered decision tree to determine access. The request value is judged by biobank staff based on defined criteria in order to avoid conflicts.

    Green-lighted tissue—the easiest to obtain, such as healthy control blood samples—can be used for just about any project, including optimization of IHC process. Yellow-lighted tissue—“the vast majority of our biobanks”—can be used only for established protocols. And red-lighted tissues—specific studies from the company, for example—are considered the highest value and are restricted to particular projects.



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