Liya Tang, Freneil Jariwala, Mark Bolgar, David K. Lloyd
Abstract:Monofunctional maleimide polyethylene glycol (mono-mal-PEG) with average molecular weight up to 40 kDa can be used as a raw material for the PEGylation of therapeutic proteins. A possible impurity in this raw material which needs to be controlled is the bisfunctional maleimide-PEG, which has a similar average molecular weight to mono-mal-PEG. Chromatographic separation and detection of low level bis-mal-PEG in mono-mal-PEG presents a major challenge because of the polydispersity of the analytes and the minor d…
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