DEEPAK K. SHARMA,1 DAVE KING,1 PETER OMA,1 CLARK MERCHANT1
1ProteinSimple Technologies Inc., 115 Terence Matthews Crescent, Ottawa Ontario CANADA, K2M2B2
PUBLICATION: The AAPS Journal. 12(3): 455-464. (2010)
DOI: 10.1208/s12248-010-9205-1
ABSTRACT: The need to monitor, measure, and control sub-visible proteinaceous particulates in biopharmaceutical formulations has been emphasized in recent publications and commentaries. Some of these particulates can be highly transparent, fragile, and unstable. In addition, for much of the size range of concern, no practical measurement method with adequate sensitivity and repeatability has been available. A complication in measuring protein particulates in many formulations is the simultaneous presence of other particle types such as silicone micro-droplets, air bubbles, and extrinsic contaminants. The need has therefore been identified for new analytical methods which can accurately measure and characterize sub-visible particulates in formulations. Micro-flow imaging has been shown to provide high sensitivity in detecting and imaging transparent protein particles and a unique capability to independently analyze such populations even when other particle types are present.
Keywords: light obscuration; micro-flow imaging; particle sizing; protein aggregation; protein formulation.
LINK TO ARTICLE: 2010_ProteinSimple_MFI applied to sbVP analysis in protein formulations.pdf
AAPS Journal Article - MFI for sbVP Analysis