mRNA Therapeutics: Fast-to-Market Strategies

By: Sarfaraz K. Niazi

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Synopsis: This book is the most comprehensive and complete treatise on nucleic acid therapeuticproducts, including mRNA vaccines, their manufacturing, formulations, andtesting for safety and efficacy. Details include cGMP-compliant manufacturing andregulatory filing steps. A new concept of “biosimilar” mRNA vaccine is presentedto secure fast approval of copies of mRNA vaccines. Projections of financial plansto establish RNA manufacturing facilities are provided, along with details of supplychain management. Finally, the future of nucleic acid products in gene therapy andother newer applications is presented, along with a perspective that all new vaccineswill be the nucleic acid type that will further provide first-time prevention of autoimmunedisorders. 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.