Single-use Mixing Systems For Protein Products: Evaluation Of Dissolution Performance And Mechanical Stress

A mixer that homogenizes quickly can still stress the protein in solution. Researchers at ten23 health (Dilara Ali, Julian Felix Plaga, Michael Adler, Hanns-Christian Mahler and Andrea Allmendinger) tested a top-mounted impeller, a novel bottom-mounted impeller and a conventional magnetic stirrer in drug substance bottles from 0.5 to 20 L.

Dissolution was timed by conductivity across fill volumes and tip speeds. Lysozyme served as the stress-sensitive model protein. The magnetic stirrer failed to dissolve the salt in some configurations, and fill volume significantly affected protein inactivation. CFD shear estimates tracked inactivation only partly (R² of 0.72), and the authors caution that the simulations characterize the mixing environment rather than predict protein stability.

Examine the dissolution and stress data by fill volume in the full paper.