title: Summary of the advanced virus detection technologies users group efforts-2013.
abstract: An informal consortium of scientists from the biopharmaceutical industry, academia, and government agencies, including regulators, coalesced during 2013 to further explore advanced virus detection technologies or appropriate applications for characterization and evaluation of biologicals. As a Parenteral Drug Association task force, the Users Group came to focus on four key work areas that required better understanding and data generation: (1) evaluation of sample preparation and processing steps for different sample types, (2) determination of method sensitivity by performing spike recovery studies using selected virus stocks, (3) development of a reliable and comprehensive viral sequence database, and (4) evaluation of bioinformatic analysis pipelines, with primary focus on next-generation DNA sequencing platforms. The year of monthly working meetings and additional subgroup discussions culminated in the 2013 PDA/FDA Advanced Technologies for Virus Detection in the Evaluation of Biologicals Conference held November 13-14, 2013 in Bethesda, MD, which provided a forum for group participants and others for data sharing and knowledge exchange. The Users Group has continued its efforts during 2014 as a PDA Interest Group with increased participation from technology developers and contract research organizations.
authors.affiliation: Merck Research Laboratories, West Point, PA, USA paul_duncan@merck.com.
authors.forename: Paul
authors.initials: P
authors.lastname: Duncan
mesh_terms: D001702:Biopharmaceutics / Q000379:methods* / Q000592:standards; D019295:Computational Biology; D003257:Consumer Product Safety; D004279:DNA, Viral / Q000235:genetics; D030541:Databases, Genetic; D004340:Drug Contamination / Q000517:prevention & control*; D059014:High-Throughput Nucleotide Sequencing; D006801:Humans; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D014773:Virology / Q000379:methods* / Q000592:standards; D014780:Viruses / Q000235:genetics / Q000302:isolation & purification*
chemical_list: D004279:DNA, Viral; D004364:Pharmaceutical Preparations
keywords: Advanced virus detection technologies; Adventitious virus; Endogenous virus; Users Group