DAVE THOMAS, DEEPAK SHARMA, CLARK MERCHANT, PETER OMA, DAVE KING
ProteinSimple, Ottawa ON, Canada
ABSTRACT:
The subvisible particles that might be present in protein therapeutics have been identified by the regulatory agencies as a potential safety issue. Some of these particles 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 accuracy has been available. The need has therefore been identified for new analytical methods which can accurately measure these particle types. Micro-Flow Imaging (MFI) is one such technique that has been shown to provide improved sensitivity and characterization potential over a wide range of sample types. This paper will describe the optimization and qualification of MFI method to characterize the particle size and levels of protein particulates. Case-Studies will be presented showing how the qualified MFI technique can be applied to quantify and analyze particles/aggregates in protein formulations. The MFI assay results showed improved sensitivity to detect subvisible particulates compared to conventional light obscuration detection, presumably due to the translucent nature of the protein particles.
PRESENTED AT:
2011 CASSS WCBP, Washington DC, USA
2011 ProteinSimple_Qualification of an MFI method to analyze particles in Bio-therapeutics.pdf
2011 ProteinSimple_Qualification of an MFI method