title: Automation and validation of DNA-banking systems.
abstract: DNA banking is one of the central capabilities on which modern genetic research rests. The DNA-banking system plays an essential role in the flow of genetic data from patients and genetics researchers to the application of genetic research in the clinic. Until relatively recently, large collections of DNA samples were not common in human genetics. Now, collections of hundreds of thousands of samples are common in academic institutions and private companies. Automation of DNA banking can dramatically increase throughput, eliminate manual errors and improve the productivity of genetics research. An increased emphasis on pharmacogenetics and personalized medicine has highlighted the need for genetics laboratories to operate within the principles of a recognized quality system such as good laboratory practice (GLP). Automated systems are suitable for such laboratories but require a level of validation that might be unfamiliar to many genetics researchers. In this article, we use the AstraZeneca automated DNA archive and reformatting system (DART) as a case study of how such a system can be successfully developed and validated within the principles of GLP.
authors.affiliation: R&D Genetics, AstraZeneca Pharmaceuticals, Mereside, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK. melissa.thornton@astrazeneca.com
authors.forename: Melissa
authors.initials: M
authors.lastname: Thornton
authors.forename: Amanda
authors.initials: A
authors.lastname: Gladwin
authors.forename: Robin
authors.initials: R
authors.lastname: Payne
authors.forename: Rachael
authors.initials: R
authors.lastname: Moore
authors.forename: Carl
authors.initials: C
authors.lastname: Cresswell
authors.forename: Douglas
authors.initials: D
authors.lastname: McKechnie
authors.forename: Steve
authors.initials: S
authors.lastname: Kelly
authors.forename: Ruth
authors.initials: R
authors.lastname: March
mesh_terms: D001331:Automation / Q000379:methods*; D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence / Q000592:standards; D004247:DNA / Q000302:isolation & purification*; D019983:Guideline Adherence / Q000592:standards; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods / Q000592:standards; D013048:Specimen Handling / Q000379:methods / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
chemical_list: D004247:DNA