Commercial Scale Production of Nanomedicines

1. Auflage 2025
ISBN: 978-1-032-77387-2
Verlag: Taylor & Francis Ltd

Buch, Englisch, 432 Seiten, Format (B × H): 156 mm x 234 mm, Gewicht: 453 g

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 commercial-scale production of nanotechnology-based products, facilities requirements, and quality assurance.

• Authored by industrial and academic experts.

• Offers regulatory guidance on CMC of nanoparticles and commercial translation of nanomedicines from the lab to market.

• Features case studies of successfully marketed nanotechnologies.

This book will serve as a valuable resource for students and researchers in pharmaceutics, pharmaceutical technology, drug delivery, drug targeting, and biomedical engineering.

It will also support 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.

Zielgruppe

Postgraduate and Professional Reference

Autoren/Hrsg.

Khopade, Ajay J.

Shahiwala, Aliasgar

Patravale, Vandana B.

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe
• Technische Wissenschaften Sonstige Technologien | Angewandte Technik Medizintechnik, Biomedizintechnik
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

0. Front Matter. 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 the 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.

Über Autor(innen)

Aliasgar Shahiwala is a 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.

Vandana B. Patravale, Professor of Pharmaceutics at ICT Mumbai, has 30 years of teaching and research experience. She has published over 300 publications, 28 granted patents, and has transferred more than 20 technologies to the industry, including several nano drug delivery systems.

Ajay Khopade is a Vice President of R&D and Heads the non-oral specialty division at Sun Pharmaceutical Industries Ltd (SPIL). He has more than 25 years corporate research experience in developing generic and differentiated products. He is an inventor of multiple commercialized platform drug delivery technologies in ophthalmology like GRF, Lipixelle, TearAct, Trisurf etc and oncology like Nanotecton protected with about 14 patents and has over 100 research publications to his credit. He has been a P4 FIT Advisory Board member for European Union’s Horizon-2020 Research and Innovation Programme under the Marie Sklodowska-Curie grant. He was a Humboldt Post-doctoral fellow at Max-Planck Institute of Colloids and Interfaces, Germany. He holds a Ph.D. degree in Pharmaceutical Sciences from the University of Sagar, India.