Publisher's Synopsis
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.
