Proper process understanding allows researchers to critically identify factors that impact the drug substance and product as well as minimize or maintain them at approved levels. As a result, the desired therapeutic outcome is achieved without compromising patient safety or introducing dangerous side effects.
Both upstream processing and downstream processing can affect critical quality attributes of the drug molecule under development. These effects can result in process-related impurities, product impurities, and post-translational modifications.
Click here to read more on how the use of surface plasmon resonance (SPR) technology may add value in drug development and how SPR assays are validated and implemented in regulated workflows.