Protein Science Group

We offer a full spectrum of analytical services

Our PSG group offers a full spectrum of protein science research services. The analytical development team is responsible for DS and DP release as well as in-process analytical method development, transfer, optimization, qualification and validation. We adapt stage-wise method validation strategy per ICH and relevant regulatory guidelines throughout the development lifecycle. We has experience in DP formulation development for different intended clinical applications and DP presentations. One of the key functions of PSG is performing product analytical characterization using our comprehensive physicochemical and biological characterization platform for early stage development such as reference standard and degradants characterization as well as demonstrating product comparability during process transfer, modification or scale-up.