This book is the most comprehensive and complete treatise on nucleic acid therapeutic
products, including mRNA vaccines, their manufacturing, formulations, and
testing for safety and efficacy. Details include cGMP-compliant manufacturing and
regulatory filing steps. A new concept of “biosimilar” mRNA vaccine is presented
to secure fast approval of copies of mRNA vaccines. Projections of financial plans
to establish RNA manufacturing facilities are provided, along with details of supply
chain management. Finally, the future of nucleic acid products in gene therapy and
other newer applications is presented, along with a perspective that all new vaccines
will be the nucleic acid type that will further provide first-time prevention of autoimmune
disorders. It is projected that both big pharma and start-ups will enter this field,
and we can expect significant additions to our drug armamentarium soon.
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
Biography
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: [email protected]
