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As pharma and biotech companies shift their focus from traditional medicine to genomic and molecular-based therapeutics, biospecimen storage (or biobanking) is becoming an essential component of medical research. Advances in molecular and genetic epidemiology have enhanced the possibility of identifying individuals with a genetic predisposition to certain cancers. Furthermore, the use of biomarkers is rapidly developing, with applications now helping to advance studies of cancer etiology, detection, treatment and prognosis. However, the validity of results from biomarker studies using archived specimens remains dependent on the integrity of the specimens and the manner in which they are collected, processed and stored (1).
Pharmaceutical and biotech firms regularly conduct a variety of testing on archived samples for various reasons. Auditing, validation and qualification processes are not performed on samples. Actual processes are audited, validated and qualified. These analyses have several key benefits to drug makers and researchers: they can expedite R&D processes for new pharmaceuticals and therapeutics, they help to gain a better understanding of disease history, testing can help detect future diseases, and most importantly, these analyses can actually reduce the time it takes to bring new life-changing drugs to market. High-throughput analysis on properly preserved biospecimens also allows researchers to detect new biomarkers and identify biological and genetic factors responsible for different drug responses across individuals or populations. |
