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Full Description
This book outlines how advances in the diverse scientific and engineering disciplines of synthetic biology, DNA synthesis, production of protein therapeutics, and bioinformatics have led to the commercialization of new complex biotherapeutic modalities in modern era, including monoclonal and multi-specific antibodies, antibody drug conjugates (ADC), fusion proteins, CAR-T and CRISPR technologies and applications, mRNA vaccines and more. Enabling operations to bring these life-changing medicines into the hands of the needy patients include regulatory submissions to authorities across the globe, as well as streamlined production across manufacturing networks deemed necessary and are outlined in dedicated chapters. Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry: Using Chemistry and Bioengineering to Improve the Performance of Biologics captures the state of the art for many of these new modalities, offering innovative approaches to treat, prevent, and in some providential cases, cure the disease. This book will be of significant interest for many disciplines engaged jointly as teams convergently in delivering these medicines: bioprocess engineers, biologists, chemists, bioengineers, genetic engineers, healthcare professionals, regulatory bodies, among pharmaceutical industry professionals as well as in academic circles.
Contents
Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry Using Chemistry and Bioengineering to Improve the Performance of Biologics An Overview.- Synthetic Biology in Drug Development and Beyond.- Increasing the Scalability of DNA Synthesis and Its Key Role in Expanding the Biopharmaceutical Discovery Process.- Advancements in the Manufacture of Monoclonal Antibodies and other Large Molecule Protein Therapeutics Recent Innovations in Cell Culture Technology Enabling Process Intensification.- Process Development and Manufacturing Considerations for Multispecific (Bispecific and Trispecific) Antibodies Case Studies.- Metabolic and process engineering to control glycan structures for biopharmaceuticals produced in cultured mammalian cells.- Even A Worm Will Turn Immunity Following AAV Vector Administration.- COVID-19 Vaccine Manufacturing Processes Making the Molecules to Solve the Pandemic.- CAR T Bioprocessing.- CRISPR Technology and its Application in Therapeutics.- Fusion Proteins Current Status and Future Perspectives.- Development of Antibody Drug Conjugates.- Mylotarg The Journey to FDA Reapproval and Broad International Approval.- Biopharmaceutical Informatics A Strategic Vision for Discovering Developable Biotherapeutic Drug Candidates.- Advanced Data Analytics Application in Bio manufacturing Processes.- Overview of Complexities of Global CMC Regulatory Affairs.- CMC Considerations for Continuous Bioprocess Design, Development and Manufacturing.- Three Decades of Advancements in Technical Transfer of Biologics a Blueprint for Advanced Therapeutics.- Emerging Biopharmaceutical Technologies and Trends.
