Flow imaging: Moving toward best practices for subvisible particle quantitation in protein products

Journal of Pharmaceutical Sciences

Volumn 102, Issue 3, 2013, Pages 1133-1134

  Wilson, Glenn A ^a   Manning, Mark Cornell ^b,c  

^a West Coast BioDesign LLC   (United States)

^b Legacy BioDesign LLC   (United States)

^c Veterinary Dentistry and Oral Surgery   (United States)

Author keywords

Analytical biochemistry; Flow imaging; Image analysis; Imaging methods; Particle size; Protein formulation; Subvisible particles

Indexed keywords

ANALYTIC METHOD; ARTICLE; CALIBRATION; COMPUTER PROGRAM; DATA ANALYSIS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IMAGING; IMAGING SYSTEM; MICROSCOPY; PARTICLE SIZE;

EID: 84878144842     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23445     Document Type: Article

References (2)

1. Carpenter JF, Randoph TW, Jiskoot W, Crommelin DJA, Middaugh CR, Winter G, Fan Y-X, Kirschner S, Verthelyi D, Kozlowski S, Clouse KA, Swann PG, Rosenberg A, Cherney B. 2009. Overlooking subvisible particles in therapeutic protein products: Gaps that may compromise product quality. J Pharm Sci 98(4):1201-1205.
2. Singh SK, Afonina N, Awwad M, Bechtold-Peters K, Blue JT, Chou D, Cromwell M, Krause H-J, Mahler H-C, Meyer BK, Nahri L, Nesta DP, Spitznagel T. 2010. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics. J Pharm Sci 99(8):3302-3321.