Our client needed a stability study of protein degradation products for regulatory documentation.
The project involved setting up a suitable LC-MS method. The goal was to separate drug-substance from degradation products. The project also included intact mass analysis to identify the individual peaks.
The client is a clinical-stage biopharmaceutical company based in the UK. The company develops novel, targeted biologics to treat cancer and autoimmune diseases.
They required a stability study as part of their drug substance documentation. The analysis included a forced degradation study requested by both FDA, EMA and ICH guidances.
The study covered the drug substance, drug product, and placebo sample. These were all exposed to high temperatures for a week before analysis by the developed LC-MS method.
The final report documented that only minor modifications occurred during the forced degradation. These were mainly oxidations of methionine. Eventually, our client included the stability study results as part of a biologics license application (BLA).