Cancer BiologybioRxiv
Analytical Comparability to Evaluate Impact of Manufacturing Changes of ARX788, an Anti-HER2 ADC in Late-Stage Clinical Development
M. P. Ramprasad, W. Yu, M. Pal…·Y. Buechler
The paper evaluates the impact of manufacturing changes on ARX788, an anti-HER2 ADC, using ICH Q5E guidelines and shows no adverse effect on product quality.
DOI 10.1371/journal.pone.0284198