An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics.
Singh
Satish K
SK
Biotherapeutics Pharmaceutical Sciences, Pfizer Inc., Chesterfield, Missouri 63017, USA. satish.singh@pfizer.com
Afonina
Nataliya
N
Awwad
Michel
M
Bechtold-Peters
Karoline
K
Blue
Jeffrey T
JT
Chou
Danny
D
Cromwell
Mary
M
Krause
Hans-Juergen
HJ
Mahler
Hanns-Christian
HC
Meyer
Brian K
BK
Narhi
Linda
L
Nesta
Doug P
DP
Spitznagel
Thomas
T
D000818:Animals; D002626:Chemistry, Pharmaceutical; D004345:Drug Industry / Q000592:standards*; D006801:Humans; D053758:Nanoparticles; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000592:standards*; D011506:Proteins / Q000737:chemistry* / Q000276:immunology / Q000627:therapeutic use*; D018570:Risk Assessment
D004364:Pharmaceutical Preparations; D011506:Proteins