Mixing Technology: Linear Scalability And Mixing Precision For Nanoparticle Formulation

Reproducibility and precision are key factors in the formulation of nanoparticle-based drug delivery systems, such as lipid nanoparticles (LNPs), polymeric nanoparticles, and hybrid carriers. Small variations in attributes like particle size, polydispersity, or encapsulation efficiency can impact drug performance, stability, and even regulatory compliance. To combat these issues, a novel mixing technology has been developed that enables precise control over nanoparticle formation, providing linearly scalable performance from early-stage R&D to full commercial production. This technology is designed to address two common concerns in pharmaceutical manufacturing: maintaining scale-up consistency and ensuring batch-to-batch reproducibility. By supporting linear scalability, formulations developed at the bench scale can be transferred to a pilot or production scale without fundamental changes to the mixing process, which may reduce the need for bridging studies.