title: Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.
authors.affiliation: Department of Pharmaceutical Sciences, Center for Pharmaceutical Biotechnology, Box 238, University of Colorado Health Sciences Center, Denver, Colorado 80262, USA. john.carpenter@uchsc.edu
authors.forename: John F
authors.initials: JF
authors.lastname: Carpenter
authors.forename: Theodore W
authors.initials: TW
authors.lastname: Randolph
authors.forename: Wim
authors.initials: W
authors.lastname: Jiskoot
authors.forename: Daan J A
authors.initials: DJ
authors.lastname: Crommelin
authors.forename: C Russell
authors.initials: CR
authors.lastname: Middaugh
authors.forename: Gerhard
authors.initials: G
authors.lastname: Winter
authors.forename: Ying-Xin
authors.initials: YX
authors.lastname: Fan
authors.forename: Susan
authors.initials: S
authors.lastname: Kirshner
authors.forename: Daniela
authors.initials: D
authors.lastname: Verthelyi
authors.forename: Steven
authors.initials: S
authors.lastname: Kozlowski
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Clouse
authors.forename: Patrick G
authors.initials: PG
authors.lastname: Swann
authors.forename: Amy
authors.initials: A
authors.lastname: Rosenberg
authors.forename: Barry
authors.initials: B
authors.lastname: Cherney
mesh_terms: D003257:Consumer Product Safety; D004340:Drug Contamination / Q000517:prevention & control*; D004355:Drug Stability; D004356:Drug Storage; D064420:Drug-Related Side Effects and Adverse Reactions; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000592:standards*; D011786:Quality Control; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins