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]
In late December 2019, a novel sickness of unknown origin was spreading across the Chinese city of Wuhan. By March of 2020, the World Health Organization declared a pandemic resulting from widespread infections from a new type of coronavirus. Prior to all this, the use of messenger RNA (mRNA) as a therapeutic agent had faced significant technical challenges. Niazi (Univ. of Illinois; Univ. of Houston) argues persuasively that the COVID-19 crisis actually caused a paradigm shift in basic mRNA research, with lasting effects affecting far more than the approval of the now well-known mRNA vaccines that were developed in response to the pandemic. Niazi's detailed coverage of the timeline of this development in the biotechnology industry occupies the first four chapters of what is arguably the most compendious treatment available on the current state of knowledge in the field of nucleic acid therapeutics. The text is organized in six chapters, the first four of which cover the core scientific principles associated with nucleic acid origins, chemistries, therapeutic technologies, and vaccine development. In the final two chapters, Niazi adopts a regulatory lens through which to explore actual processes of vaccine manufacture and related government oversight. The text is illustrated and replete with suggested readings. Knowledgeable readers will appreciate the detailed index.
The title is a Choice review and is highly recommended (as per the review).
-- J. A. Hewlett, Finger Lakes Community College
