Automation and validation of DNA-banking systems.
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.
Thornton
Melissa
M
R&D Genetics, AstraZeneca Pharmaceuticals, Mereside, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK. melissa.thornton@astrazeneca.com
Gladwin
Amanda
A
Payne
Robin
R
Moore
Rachael
R
Cresswell
Carl
C
McKechnie
Douglas
D
Kelly
Steve
S
March
Ruth
R
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
D004247:DNA