Drug Particle Engineering Enabled by Soft Matter Concepts
Advances in modern drug manufacturing have primarily focused on discovery and synthesis of the active pharmaceutical ingredient (API). However, new processes to turn the API into the final drug product are still needed to streamline multi-step processes, enhance absorption of class II and IV APIs, and enable a new delivery mode for biologics.
In this talk, I will discuss technologies being developed in my group which leverage soft matter materials and flow physics for advanced pharmaceutical manufacturing. I will first discuss technologies we are developing for small molecule oral formulations — introducing themes of microfluidic enabled coformulation that blur the drug substance/product boundary and bottom-up formation of embedded API nanocrystals. Next, I will discuss biologics formulations with a focus on monoclonal antibodies (mAbs).
Subcutaneous administration is a desired route for mAbs. However, formulating mAbs for small injection volumes at high concentrations with suitable stability and injectability is a significant challenge. I will present technologies that combine the stability of solid forms of antibodies (crystalline or amorphous) with the injectability and tunability of soft hydrogel particles.
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