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, C. Chen, S. Paruchuri, L. Skidmore, N. Knudsen, M. Allen, 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.
bioRxiv · Mar 27, 2023Cancer Biology