Commercial Scale Production of Nanomedicines

Inbunden, Engelska, 2025

Av Aliasgar Shahiwala, Ajay J. Khopade, Vandana B. Patravale, United Arab Emirates) Shahiwala, Aliasgar (Dubai Pharmacy College, India) Patravale, Vandana B. (Institute of Chemical Technology, Mumbai

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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 expertsOffers regulatory guidance on the chemistry, manufacturing, and controls (CMC) of nanoparticles and commercial translation of nanomedicines from the lab to marketFeatures case studies of successfully marketed nanotechnologiesThis 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.

Produktinformation

Utgivningsdatum2025-08-20
Mått156 x 234 x 26 mm
Vikt910 g
FormatInbunden
SpråkEngelska
Antal sidor393
FörlagTaylor & Francis Ltd
ISBN9781032773872

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Aliasgar Shahiwala is Professor in the Department of Pharmaceutical Sciences at Dubai Pharmacy College for Girls, which is affiliated with Dubai Medical University. He is a renowned researcher with an impressive portfolio, having edited eight books, authored 19 chapters, and published over 60 articles. With more than 20 years of experience in academia and over three years in the industry, he has made significant contributions to the pharmacy field.Ajay J. Khopade is Vice President of Research and Development and heads the non-oral specialty division at Sun Pharmaceutical Industries Ltd. (SPIL). He has more than 26 years of corporate research experience in developing generic and differentiated products. He is an inventor of multiple commercialized platform drug-delivery technologies in ophthalmology and oncology, such as GRF, Lipixelle, TearAct, Trisurf, and Nanotectons, protected by over 14 patents, and he has more than 100 research publications to his credit. He has been a P4 FIT Advisory Board member for the European Union’s Horizon 2020 Research and Innovation Programme under the Marie Skłodowska-Curie grant. He was a Humboldt post-doctoral fellow at the Max-Planck Institute of Colloids and Interfaces in Germany. Dr. Khopade earned a PhD in pharmaceutical sciences at the University of Sagar, India.Vandana B. Patravale is Professor of Pharmaceutics at the Institute of Chemical Technology (ICT), Mumbai, with 30 years of teaching and research experience. She has published over 300 publications, received 28 granted patents, and has transferred more than 20 technologies to the industry, including several nano drug delivery systems.

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.