title: Detection breadth and limits for potential adventitious/endogenous contaminants in biopharmaceutical processes: a reality check for innovative methods.
abstract: In this presentation we address the "gold standards" among diagnostic tests used to detect some potential adventitious and endogenous contaminants in human biologics and vaccines, reflecting on the breadth as well as limits of detection of these assays. This perspective may help developers of innovative diagnostics to address the unique needs of this highly regulated industry.
authors.affiliation: Merck Research Laboratories, West Point, PA 19486-0004, USA. paul_duncan@merck.com
authors.forename: P
authors.initials: P
authors.lastname: Duncan
authors.forename: L
authors.initials: L
authors.lastname: McKerral
authors.forename: S
authors.initials: S
authors.lastname: Feng
authors.forename: P K
authors.initials: PK
authors.lastname: Tsai
mesh_terms: D001419:Bacteria / Q000302:isolation & purification; D004340:Drug Contamination / Q000517:prevention & control*; D005658:Fungi / Q000302:isolation & purification; D004364:Pharmaceutical Preparations / Q000032:analysis*; D016133:Polymerase Chain Reaction / Q000379:methods; D011786:Quality Control; D014780:Viruses / Q000302:isolation & purification
chemical_list: D004364:Pharmaceutical Preparations