Analytical comparability to evaluate impact of manufacturing changes of ARX788, an Anti-HER2 ADC in late-stage clinical development.

PLoS One · 2023 · PMC10332591 · PMID 37428761

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a clear trendno p-value reported

A clear trend in reduction of main peak purity and concomitant appearance of acidic and basic species for both pre-change and reconstituted post-change Lyo 1 can be observed, while the lyophilized post-change DP purity remains unchanged.

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