Please note that this will be a remote presentation
- Mixing step of a drug product (DP) or drug substance (DS) during the manufacturing should enable sufficient homogenization of the material at desired time but, on the other hand, should not influence its quality. Mixing is known to cause particle generation in biological drugs.
- The mixing process is usually assessed during process development on smaller scales and is then confirmed in a production. However, development usually takes place in models that lack sufficient power for accurate scalability. This leads to challenges, since designs do not predict actual situation on a large scale.
- An appropriate design can be obtained by considering computational fluid dynamics (CFD) simulations. The calculated fluid velocities along the streamlines in CFD models provide a description that is specific for a given large scale vessel. The selected SDM is then used to assess the influence of mixing on DP or DS quality in laboratory.
Omar Naneh, Senior scientist BPD DPD Operational Sciences, Novartis