Exact(6)
Light obscuration, flow microscopy, and Coulter counter instruments are based on different principles and therefore require different operating conditions.
The presence of silicon oil droplets allowed an efficient testing of the light obscuration, flow microscopy, and Coulter counter instruments.
The aim of the present work was to identify the limitations of light obscuration, flow microscopy, and the Coulter counter when analyzing protein solutions.
In the present paper, we have investigated the performance of light obscuration, flow microscopy, and Coulter counter instruments for particle counting and sizing in protein formulations.
Light obscuration, flow microscopy, and the Coulter counter are three commercially available particle-counting techniques able to characterize particles >2 μm.
For the comparison of light obscuration, flow microscopy, and the Coulter counter methods, the contents of ~25 aged MAb1 pre-filled syringes were pooled and mixed in an Accuvette ST container (Beckman Coulter, Fullerton, CA, USA).
Similar(54)
We have observed that a high solution viscosity could compromise measurements on current light obscuration and flow microscopy instruments.
Light obscuration and flow microscopy showed different sensitivities to protein concentration.
We investigated the effect of high protein concentration on three particle-counting methods: Coulter counter, light obscuration, and flow microscopy.
Inconsistent results were observed between different protein concentrations in the range 7.5 150 mg/ml for particles <10 μm studied by optical techniques (light obscuration and flow microscopy).
Nevertheless, protein particles, especially in high-concentration protein formulations, were shown to pose specific challenges to optical-based particle-counting techniques: light obscuration and flow microscopy.
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