DEEPAK SHARMA, CLARK MERCHANT, DAVE KING
ProteinSimple, Ottawa, ON, Canada,
ABSTRACT:
The subvisible particles that can be present in protein therapeutics have been identified as a potential safety concern. These protein-based particulates have physical properties different from the existing reference standards used to calibrate and validate optical particle analyzers. Therefore, there is a need to develop a new reference material, with similar properties to protein aggregates, for validation and calibration of particle analyzers. Preliminary results will be presented on measurement issues for characterization of protein particulates, development of a surrogate sensitivity reference material, applicability to multiple detection methods, and the need for standardized methods.
PRESENTED AT:
2011 CHI PepTalk, San Diego CA, USA
2011 ProteinSimple_Development of a sensitivity reference material for MFI.pdf
2011 ProteinSimple Development of a sensitivity