1st Edition
Commercial Scale Production of Nanomedicines
1. Challenges for Commercial Translation of Nanomedicines: From Lab Scale to Production Scale
Ajay J. Khopade and Malay Shah
2. Regulatory Guidance on CMC of Nanoparticles
Ganesh Jadhav, Amit Dabke, and Ajay J. Khopade
3. Infrastructure Requirements for Nanomedicine Manufacturing
Vivek Patel, Ankur Gupta, Kartik Hariharan, Arindam Halder, and Udaykumar Pandit
4. Synthesis of Nanostructures: Bottom-Up and Top-Down Approaches
Popat S. Kumbhar, Prafull Kolekar, Preeya Negi, Ankita Anure, Kaustubh Ajit Kolekar, Sukriti Vishwas, Sachin Kumar Singh, John Disouza, and Vandana B. Patravale
5. PEGylation and Other Stealthing Techniques
Susanta Kumar Rout, Saikat Ghosh, and Ajay J. Khopade
6. Production of Lipid Nanoparticles for mRNA and Vaccines: An Industry Perspective
Brijesh Patel, Homraj Mahajan, Apoorva Mirche, Arindam Halder, Shubhadeep Banerjee, and Ajay J. Khopade
7. Commercial Production of Liposomes: Advancements and Innovation in Manufacturing Processes, Quality Assurance, and Control
Aliasgar Shahiwala
8. Production of Polymer-Based Nanoparticles
Dipankar Bhadra and Sulekha Bhadra
9. Large-Scale Production of Nanocrystals for Pharmaceutical Use
Aliasgar Shahiwala
10. Large-Scale Production of Inorganic/Metallic Nanoparticles
Aliasgar Shahiwala
11. Scaleup of Nano/Micro Emulsions
Aliasgar Shahiwala
12. Nanocoated Medical Devices
Sarika A. Jadhav, Manashvi R. Bhanushali, and Vandana B. Patravale
Biography
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.
