After process scale-up, our client observed that their antibody product was less stable than the small-scale production batches.
The cause of the decreased stability was uncovered by combining several characterization methods that gave the client the complete overview of their antibody’s structural features.
This client, a European pharmaceutical company, discovers and develops immunotherapeutic antibodies to treat cancer. They have several drug candidates in pre-clinical and phase 1-2.
Over the years, they have used Alphalyse for individual analyses on early-stage products, including protein identification by nano LC-MS/MS.
However, when production was scaled up one product showed decreased stability. Therefore, a combination of analyses, including intact mass analysis, peptide mapping, N- and C-terminal sequencing, and disulfide bridge analysis were performed to locate the mAb’s structural differences causing issues with stability.
Based on the results, the client could intelligently optimize the process to overcome the problem. Afterwards, they decided to include this characterization program as a quality check of future batches.