Praval P. Shah, Analytical Associate III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc recently shared some advice on how to prevent contamination and ensure quality.
“It can begin with discarding of few particulated vials and could end up with a probable rejection of the entire batch. Therefore, investigation of the source of particulate contamination and its elimination is imperative to ensure continuous quality”.
Praval P. Shah, Analytical Associate III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc. will be presenting "Analysis of Sub-Visible Particulates in Antibody-Maytansinoid Conjugates" at IBC's Drug Product Quality Summit this coming December 3-4, 2012 in Raleigh, North Carolina. For more information on this event, download the agenda.
Featured Session: Analysis of Sub-Visible Particulates in Antibody-Maytansinoid Conjugates
Featured Speaker: Praval P. Shah, Analytical Associate III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc
About the session: Antibody-Maytansinoid Conjugates (AMCs) are administered intravenously and sub-visible particulate (SVP) levels need to meet compendial specifications. The relatively large volume requirement of the compendial light obscuration method (USP<788>) limits its use in early stage development. This presentation focuses on the evaluation of two reduced injection volume light obscuration methods for quantifying sub-visible particulates in AMC samples. The analysis of conjugate samples using micro-flow imaging is also discussed.
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