1st Edition

mRNA Therapeutics Fast-to-Market Strategies

By Sarfaraz K. Niazi Copyright 2023
    326 Pages 73 B/W Illustrations
    by CRC Press

    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


    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]