Handbook of Biological Therapeutic Proteins (2nd Edition)
Handbook of Biological Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues
English | 2024 | ISBN: 103248960X | 413 Pages | PDF (True) | 48 MB
English | 2024 | ISBN: 103248960X | 413 Pages | PDF (True) | 48 MB
Since 1972, which marks the invention of recombinant engineering, more than 500 therapeutic proteins have been approved for clinical use. Today, biological drugs constitute almost 70% of all new drugs and have a biological origin. The first edition of this book dealt with biosimilars, and this edition (i.e., the second edition) focuses on new drugs, yet limits to therapeutic proteins. Newer technologies for drug development represent the updated topics in the book and include repur-posing, AI- driven identification of newer designs, novel expression systems, manufacturing using these systems, rapidly changing regulatory pathways, and legal hurdles. This edition discusses how to identify, develop, manufacture, and take multibillion dollar products to market within the shortest possible time.