The formulation and the technological advancements in RNA biology, chemistry, stability, and encapsulated delivery systems that have enabled the development of fully synthetic m RNA vaccines are discussed in this volume. The applications of the m RNA technology is covered, focusing on infectious diseases but also touching on other indications, such as immunotherapies and molecular therapies. Potent and long-lasting immune responses observed in animal models, encouraging data from early human clinical studies, together with the success of two m RNA-based COVID-19 vaccines support the use of m RNA-based vaccination as an attractive alternative to conventional vaccine approaches. Consequently, the development progress of the technology, particularly on production, capabilities, and clinical development is reviewed. Topics on safety, regulatory issues, and possible challenges to the m RNA vaccination approach round off this book. Thanks to their high potency, the prospect for generic, low-cost manufacturing processes, and entirely synthetic nature, the future for m RNA vaccines is highly promising. Importantly, m RNA vaccines have the potential to minimize the time between pathogen identification and vaccine release with a huge impact on public health.
As the m RNA-based vaccination technology has been progressing rapidly, the book is intended to be an end-to-end review series, covering everything from basic RNA biology and preclinical studies to the manufacturing strategy, clinical development and regulatory approval. It provides established RNA researchers and developers with updates on the latest advancements in the field and allows for a quick but comprehensive overview of this transformative technology, its application, and future potential.
Tabla de materias
Preface.- m RNA-based vaccines and mode of action.- Self-Amplifying m RNA-Based Vaccine Technology and its Mode of Action.- Formulation and Delivery Technologies for m RNA Vaccines.- Messenger RNA-based vaccines against infectious diseases.- Emerge gate for Therapeutics applications of m RNA based drug.- Clinical Development of m RNA Vaccines: Challenges and Opportunities.- Regulatory Considerations on the Development of m RNA Vaccines.
Sobre el autor
Dr. Dong Yu currently is Senior Vice President of Research at Dynavax Technologies. Prior to joining Dynavax, Dr. Yu was the Head of Preclinical R&D US at GSK Vaccines. He received the Ph D from University of Connecticut Health Center. He was a faculty member at Washington University in Saint Louis and the Head of Microbial Molecular Biology at Novartis Vaccines prior to joining GSK Vaccines in 2015. Dr. Yu authored over 40 publications in various journals and books. His publications reflect his research interests in virology, infectious diseases, and vaccines.
Dr. Benjamin Petsch, Senior Director Prophylactic Vaccine Research at Cure Vac AG, Benjamin Petsch joined Cure Vac in 2010 as a scientist in the vaccines department developing m RNA based vaccines against infectious diseases and is heading the department since 2013. He received his university degree from Ludwig-Maximilians-University of Munich and performed his doctoral thesis at the Friedrich-Loeffler-Institut, Tübingen, where he continued as a postdoc and research group leader working on m RNA vaccination against Influenza and on intervention of Influenza replication using small molecules. Dr. Petsch has a 10+ years scientific experience on m RNA based prophylactic vaccines.
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