GMP-validated MS-based residual enzyme analysis

Alphalyse has performed the world’s first GMP-validated mass spectrometry-based residual enzyme analysis

Enzyme-assisted process steps are sometimes part of the manufacturing of new recombinant protein drugs.

According to ICH guidelines, safety and quality risk management must be employed to prevent process-added enzymes from co-purifying with the final drug product. However, suitable ELISAs may not exist to demonstrate the clearance of these specific enzymes.

In collaboration with 89bio, a biotech developer of therapies for liver and cardiometabolic diseases, Alphalyse has developed and validated an LC-MS-based assay with a low-to-sub ppm detection limit.

The assay enables reliable and reproducible identification and quantification of specific residual enzymes by targeted LC-MS using Multiple Reaction Monitoring (MRM) technology.

The analysis is performed according to GMP standards, making it fit for batch-release testing.