PMID- 25421933
OWN - NLM
STAT- MEDLINE
DCOM- 20160624
LR  - 20220119
IS  - 1520-6017 (Electronic)
IS  - 0022-3549 (Linking)
VI  - 104
IP  - 2
DP  - 2015 Feb
TI  - An interlaboratory comparison of sizing and counting of subvisible particles 
      mimicking protein aggregates.
PG  - 666-77
LID - 10.1002/jps.24287 [doi]
AB  - Accurate counting and sizing of protein particles has been limited by 
      discrepancies of counts obtained by different methods. To understand the bias and 
      repeatability of techniques in common use in the biopharmaceutical community, the 
      National Institute of Standards and Technology has conducted an interlaboratory 
      comparison for sizing and counting subvisible particles from 1 to 25 mum. 
      Twenty-three laboratories from industry, government, and academic institutions 
      participated. The circulated samples consisted of a polydisperse suspension of 
      abraded ethylene tetrafluoroethylene particles, which closely mimic the optical 
      contrast and morphology of protein particles. For restricted data sets, agreement 
      between data sets was reasonably good: relative standard deviations (RSDs) of 
      approximately 25% for light obscuration counts with lower diameter limits from 1 
      to 5 mum, and approximately 30% for flow imaging with specified manufacturer and 
      instrument setting. RSDs of the reported counts for unrestricted data sets were 
      approximately 50% for both light obscuration and flow imaging. Differences 
      between instrument manufacturers were not statistically significant for light 
      obscuration but were significant for flow imaging. We also report a method for 
      accounting for differences in the reported diameter for flow imaging and 
      electrical sensing zone techniques; the method worked well for diameters greater 
      than 15 mum.
CI  - (c) 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.
FAU - Ripple, Dean C
AU  - Ripple DC
AD  - Biomolecular Measurement Division, National Institute of Standards and 
      Technology, Gaithersburg, Maryland.
FAU - Montgomery, Christopher B
AU  - Montgomery CB
FAU - Hu, Zhishang
AU  - Hu Z
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20141124
PL  - United States
TA  - J Pharm Sci
JT  - Journal of pharmaceutical sciences
JID - 2985195R
RN  - 0 (Fluorocarbons)
RN  - 0 (Protein Aggregates)
RN  - 25038-71-5 (poly(ethylene-tetrafluoroethylene))
SB  - IM
MH  - Biomimetic Materials/*analysis/metabolism
MH  - Clinical Laboratory Techniques/*standards
MH  - Drug Industry/*standards
MH  - Fluorocarbons/*analysis/metabolism
MH  - *Particle Size
MH  - *Protein Aggregates/physiology
OTO - NOTNLM
OT  - image analysis
OT  - imaging methods
OT  - light scattering
OT  - microparticles
OT  - particle size
OT  - physical characterization
EDAT- 2014/11/26 06:00
MHDA- 2016/06/25 06:00
CRDT- 2014/11/26 06:00
PHST- 2014/10/02 00:00 [received]
PHST- 2014/10/30 00:00 [revised]
PHST- 2014/11/03 00:00 [accepted]
PHST- 2014/11/26 06:00 [entrez]
PHST- 2014/11/26 06:00 [pubmed]
PHST- 2016/06/25 06:00 [medline]
AID - S0022-3549(15)30232-X [pii]
AID - 10.1002/jps.24287 [doi]
PST - ppublish
SO  - J Pharm Sci. 2015 Feb;104(2):666-77. doi: 10.1002/jps.24287. Epub 2014 Nov 24.