Quality Control of Nanoparticulate Drugs: Manufacturing, Characterization and Regulatory Considerations 2013

There have been significant advances in the development and application of nanoparticle technologies in drug formulation and delivery. While there are few nanoparticle-based drug products on the market, many more potential products are at various stages of preclinical and clinical development. Proactively and timely understanding and addressing manufacturing and characterization challenges and quality control aspects are critical to the successful advancement and broad acceptance of nanoparticle-based drug products. Using bottom-up and top-down approaches during the manufacturing of nanoparticles and identifying critical process parameters along with the development and validation of suitable characterization methods would ensure batch-to-batch consistency and in vitro/in vivo performance.
The objective of this short course is to address the aforementioned areas and discuss bottom up particle fabrication methods to manufacture nanoparticles, as well as top down manufacturing methods such as ultrasound, media milling, and high pressure homogenization. Method validation and setting drug product specifications will then be presented along with in vitro/in vivo characterization methods, physical and chemical stability assessment. Regulatory considerations will be highlighted throughout the course and emphasized in the last lecture followed by a panel discussion.
Upon completion of the short course participants should be able to 1) discuss quality control aspects of nanoparticulate drugs from leading academic, industrial, and government scientists as related to manufacturing, in vitro/in vivo characterization, and regulatory aspects; 2) describe physical/chemical stability and other product development challenges with nanopharmaceuticals and identify a path to commercialization; and 3) apply acquired knowledge to the design and development of nanotechnology-enabled drug delivery systems in a rational, timely, and cost-effective manner.