Case study

We fixed a scale-up problem & now use Alphalyse to test all batches

Combining mass spec analyses for mAb characterization and batch-to-batch comparison

After a process scale-up, a mAb product was less stable than in the small-scale production batches. Combining several characterization methods uncovered the cause of the decreased stability and gave our client an overview of their antibody’s structural features.

One of our clients, a European pharmaceutical company, is developing immunotherapeutic antibodies for cancer treatment. The company has several drug candidates in pre-clinical and phase 1/2 trials.


Characterization design

The client has used Alphalyse for individual analyses of early-stage products, including protein identification by nanoLC-MS/MS.

Protein Identification

List of protein hits from Protein ID report.


However, after a process scale-up, our client observed that one of their antibody products showed decreased stability. The client therefore asked us to perform a combination of mass spectrometry analyses for product characterization, including intact mass analysis, peptide mapping, N- and C-terminal sequencing, and antibody disulfide bonds analysis, to identify the structural features causing issues with the mAb’s stability.

Data from analysis of mAb

Results from Intact mass analysis of one DS batch. Both the reduced and native antibody was analyzed.


Based on our findings, the client could intelligently optimize their process to overcome the stability issue. The client now uses our characterization program as a quality check for all future product batches.

Testimonial Alphalyse

‘With the results from the extensive characterization, we identified a scale-up problem and could optimize the process to increase mAb stability. Now, we use the analysis on an ongoing basis to test the quality of all our batches.’

Director, Protein & Analytical Chemistry

Research-based pharmaceutical company

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