Case study

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 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.


Project design

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).

Testimonial Alphalyse

‘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.’

CMC Project Leader, R&D

UK bioharma company

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