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The detection and quantification of particulate matter in biologics raises new issues from those found in traditional parenterals covered by USP <788>. Protein-based therapeutics are different in that they can form intrinsic large-size particulates in the form of protein aggregates. Unlike extrinsic particulates, which are usually solid, and therefore high contrast and easier to detect, protein aggregates tend to be amorphous and fairly transparent. As a result, the light obscuration analytical technique specified by USP <788> for characterization of particulates has difficulty properly characterizing these aggregates. Light obscuration is not particularly good at “seeing” transparent objects, and hence may mischaracterize the size of, or even completely miss, protein aggregate particles. Dynamic Image Analysis has the potential to overcome these limitations by
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being able to detect and characterize both the size and shape of
proteinaceous particulates.
This webinar first discusses the historical methodologies used to characterize sub-visible particulates in parenterals, including current and future USP standards efforts. It's followed by a discussion of three important factors which need to be understood if considering Dynamic Image Analysis for particulate characterization: resolution, image quality and thresholding. Finally, real-world results of sub-visible particulate characterization using several orthogonal instrument methodologies are discussed.
Why you should view this webinar:
• Understand past, present, and potential future USP standards pertaining to sub-visible particulates
• Understand issues associated with using Dynamic Image Analysis for characterizing sub-visible particulates
• See real-world
comparisons of particulate characterization using different analytical methods