Good Manufacturing Practices (GMP) of Magnetic Nanoparticles

Abstract

Recent advances in magnetic nanoparticles (MNPs) have shown that nanomedicine may offer solutions for unmet problems. However, only a small number of these developments can make it to the world market in comparison the amount of published work. The challenges of bridging the translational gap between lab and practice in the industrial context should be considered at early stages of development. These issues should be addressed to ensure compliance with regulatory requirements at the later stages and to enable market penetration. In this way, the knowledge produced at the bench can be successfully transferred to bedside. Establishment of good manufacturing practice (GMP) compliant-nanoparticle (NP) manufacturing in large scale is the prerequisite of successful transfer. These methods should be designed taking GMP requirements and commercial batch size into consideration. Continuous manufacturing technologies are highlighted among the NP manufacturing methods due to their high GMP compatibility and unlimited batch size. Particle quality according to pharmaceutical standards is another important aspect besides the choice of manufacturing methods. Particles properties, such as particle size and particle size distribution, are required to be efficiently controlled without any batch-to-batch variations. Continuous manufacturing methods enable the control on critical quality attributes with adjustment of production parameters, which are also closely monitored with in-process controls.