Evonik Health Care

Lipid nanoparticle (LNP) formulation development begins on a small scale, often with homemade or benchtop setups, using syringe pumps and easily accessible micro-mixing systems. Once a promising formulation has been identified, the next step is to transition to standardized large-scale impingement mixing systems, such as the high flow T-mixing pumps that were used to produce the COVID-19 vaccines (Sealy 2021). Formulators need to consider a number of factors when scaling up novel LNP systems. These include flow rates that affect LNP particles, solvent removal, risk factors when changing equipment, and the impact of tangential flow filtration sensitivity. In this technical note, we discuss these factors and what needs to be considered when developing a cost- and time efficient large-scale process.

What actions can we as manufacturers take to make a difference to sustainability without disrupting the supply of our life-saving medicines?

Review of a modular aseptic filling platform for use with complex and personalized parenteral drug products in powder, liquid, suspension or combination form.