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Full Description
The commercial production of nanomedicines involves challenges related to scalability, reproducibility, safety, and regulatory approvals. It is essential to have access to a preparation method that can produce large quantities of nanomedicines in a scalable way while maintaining a consistently high level of quality and batch-to-batch reproducibility. This book provides comprehensive guidance on the commercial-scale production of nanotechnology-based products, facilities requirements, and quality assurance.
Authored by industrial and academic experts
Offers regulatory guidance on the chemistry, manufacturing, and controls (CMC) of nanoparticles and commercial translation of nanomedicines from the lab to market
Features case studies of successfully marketed nanotechnologies
This book serves as a valuable resource for students and researchers in pharmaceutics, pharmaceutical technology, drug delivery, drug targeting, and biomedical engineering.
It also supports industrial personnel working in nanomedicine manufacturing with the latest updates and those seeking to switch or extend their current product range to nanomedicines or start a new venture in nanomedicine production.
Contents
1. Challenges for Commercial Translation of Nanomedicines: From Lab Scale to Production Scale. 2. Regulatory Guidance on CMC of Nanoparticles. 3. Infrastructure Requirements for Nanomedicine Manufacturing. 4. Synthesis of Nanostructures: Bottom-Up and Top-Down Approaches. 5. PEGylation and Other Stealthing Techniques. 6. Production of Lipid Nanoparticles for mRNA and Vaccines: An Industry Perspective. 7. Commercial Production of Liposomes: Advancements and Innovation in Manufacturing Processes, Quality Assurance, and Control. 8. Production of Polymer-Based Nanoparticles. 9. Large-Scale Production of Nanocrystals for Pharmaceutical Use. 10. Large-Scale Production of Inorganic/Metallic Nanoparticles. 11. Scaleup of Nano/Micro Emulsions. 12. Nanocoated Medical Devices.
