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Microfluidics for Formulation and Scale-Up Production of Nanoparticles for Biopharma Industry

  • Mingzhi Yu,
  • Allen Mathew,
  • Dongsheng Liu,
  • Yixin Chen,
  • Jing Wu,
  • Yuguo Zhang,
  • Nan Zhang

摘要

The biopharmaceutical market is undergoing rapid growth, particularly in the realm of nanomedicine, where nanoparticles containing biologics are prevalent. The success of this market is exemplified by proven instances like lipid nanoparticles (LNP), such as those utilized in COVID-19 vaccines. However, traditional methods of nanoparticle formulation and scale-up face significant limitations. In this chapter, we focus on nanoparticles for clinical medicine, covering screening formulations, scale-up productions, and characterizations. It commences with an introduction to the importance of biopharmaceutical nanoparticles and their market. The subsequent section delves into nanoparticle formulations, emphasizing the timesaving advantages of screening. The chapter explores the factors influencing nanoparticle formulations, showcasing various microfluidic channels for manufacturing diverse lipid-based and polymeric nanoparticles. Scale-up productions are also discussed, addressing their importance, strategies, and associated challenges. Additionally, the characterization of nanoparticles is considered, encompassing in vitro and in vivo properties, providing insights into nanoparticles’ safety. Finally, the chapter explores future trends and emerging technologies in this dynamic field.