Scaling nanopharmaceutical production for personalized medicine: challenges and strategies

Abstract

Nanomedicine has emerged as a transformative field, offering enhanced drug delivery systems with reduced toxicity through the use of nanopharmaceuticals. Scaling up the production of these systems is critical for the successful translation of personalized nanomedicine into clinical practice. This review addresses the challenges and strategies involved in large-scale manufacturing, focusing on key methodologies such as nanocrystallization, extrusion, supercritical fluid technology, and microfluidics. A detailed comparative analysis of these production methods reveals their scalability, cost implications, and impact on nanoparticle characteristics, such as size and reproducibility. Additionally, we examine the complex regulatory landscape, highlighting regional differences in approval requirements from agencies. These regulatory variations pose significant challenges for global manufacturers seeking to scale up production while maintaining compliance with diverse standards. The review also explores the critical role of good manufacturing practices (GMP) and quality-by-design approaches in ensuring batch-to-batch consistency, offering a roadmap for overcoming the technical and regulatory hurdles essential for advancing nanomedicine to widespread clinical applications. Therefore, by addressing these barriers, nanopharmaceuticals hold the potential to revolutionize personalized medicine with more effective, targeted therapies for complex diseases.