After process scale-up, our client observed that their antibody product was less stable than the small-scale production batches.
Combining several characterization methods uncovered the cause of the decreased stability and also 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.
Characterization design
Over the years, they have used Alphalyse for individual analyses on early-stage products, including protein identification by nanoLC-MS/MS.
However, when the client scaled up the production, one product showed decreased stability. Therefore, a combination of analyses, including intact mass analysis, peptide mapping, N- and C-terminal sequencing, and antibody disulfide bonds 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. Afterward, they decided to include this characterization program as a quality check of future batches.
