Process Matters: Manufacturing Robust Lipid Nanoparticles

Lipid nanoparticles (LNPs) are an important delivery platform with enormous potential for vaccines, therapeutic gene editing, in vivo biologic expression, and in vivo CAR-T therapies. However, as complex medicines, LNPs exemplify how “the process defines the product.” Turning promising science and nanomedicines into effective, reliable global therapies requires careful consideration of robust, scalable process design from the earliest stages of innovation to ensure successful manufacturing.

This talk will provide an overview of the roadmap for LNP design and development, from concept to product. It will then focus on the importance of process optimisation and the definition of key process parameters that influence the critical quality attributes (CQAs) of LNPs—attributes that ultimately determine product performance and patient outcomes. Practical examples of some factors affecting CQAs and performance will be shared. The talk will conclude with reflections on some emerging and alternative approaches to LNP manufacture.