Stability study – an important part of biologics license application

Forced degradation study of production batches by UV-HPLC-MS

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 for identification of the individual peaks. 

The client is a clinical-stage biopharmaceutical company, who is based in the UK. The company develops novel, targeted biologics – for treatment of cancer and autoimmune diseases.

They required a stability study as part of their drug substance characterization. The analysis included a forced degradation study as 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 temperature for a week, before analyzed 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).


UK biopharma company_logo
"“We received a very professional report. It included an excellent overview of the peaks and their identity, both in the different batches and in the degradation samples. With the documentation from the study, we finally had everything we needed to send in the biologics license application (BLA) for FDA approval.”"

UK biopharma company- CMC Project Leader, R&D

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