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The paradigm shift during the pandemic now allows us to develop new biologics that were never possible before and find treatments for autoimmune disorders that remain untreatable.
List of contents
Background.
1. The Genome Machine.
2. Understanding Nucleic Acids.
3. RNA Therapeutics.
4. Nucleoside Vaccines.
5. cGMP mRNA Vaccine Manufacturing.
6. Regulatory Guidance.
Appendix 1. Covid-19 mRNA Vaccine Manufacturing Feasibility.
Appendix 2. Pharmacopeial Testing.
Appendix 3. Suggested Readings
About the author
Sarfaraz K. Niazi, Ph.D., is an Adjunct Professor at the University of Illinois and the University of Houston; he has authored 60+ major books, 100+ research papers, and 100+ patents, mainly in the field of bioprocessing, drug discovery, drug formulations, thermodynamic systems, alcohol aging, nutraceuticals, and treatment of autoimmune diseases. He has hands-on experience establishing biotechnology projects, from concept to market, including FDA approvals. In addition, he has first-hand experience in establishing RNA therapeutic product development and manufacturing, including the mRNA vaccine for COVID-19. He also serves as an advisor to major pharmaceutical and biopharmaceutical companies, regulatory agencies, and many heads of state. He is also a patent law practitioner. Email: niazi@niazi.com
Summary
The paradigm shift during the pandemic now allows us to develop new biologics that were never possible before and find treatments for autoimmune disorders that remain untreatable.
