Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.
Carpenter
John F
JF
Department of Pharmaceutical Sciences, Center for Pharmaceutical Biotechnology, Box 238, University of Colorado Health Sciences Center, Denver, Colorado 80262, USA. john.carpenter@uchsc.edu
Randolph
Theodore W
TW
Jiskoot
Wim
W
Crommelin
Daan J A
DJ
Middaugh
C Russell
CR
Winter
Gerhard
G
Fan
Ying-Xin
YX
Kirshner
Susan
S
Verthelyi
Daniela
D
Kozlowski
Steven
S
Clouse
Kathleen A
KA
Swann
Patrick G
PG
Rosenberg
Amy
A
Cherney
Barry
B
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*
D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins