Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues

Since 1972 when recombinant engineering was invented, over 500 therapeutic proteins have been approved. Today, biological drugs constitute almost 70% of all new drugs and are of biological origin. The first edition of this book dealt with biosimilars, the second focuses on new drugs yet limits to therapeutic proteins. The newer technologies for development represent the updated topics in the book and include repurposing, AI-driven identification of newer designs, novel expression systems and manufacturing, fast changing regulatory pathways, and legal hurdles. Discusses how to identify, develop, manufacture and take multibillion dollar products to market in the shortest possible time.

Features

• Complete and thorough coverage of the regulatory and technological challenges of developing generic therapeutic proteins.
• Comprehensive, discovery to market, newer technologies, regulatory planning and IP hurdles are included that are not found elsewhere.
  
• Expanded volume that must be in the hands of every company interested in biological drugs, including the mRNA companies fast appearing on the market.
• Discusses how to identify, develop, manufacture and take multibillion dollar products to market in the shortest possible time.

• Renowned author and entrepreneur in the field of drug discovery and production.

Sarfaraz K Niazi, Ph.D., is an Adjunct Professor at the University of Illinois. He has authored 60+ major books, 100+ research papers, and 100+ patents, mainly in bioprocessing. He has hands-on experience establishing biopharmaceutical projects, from concept to market, including setting up the first biosimilar company in the US and leading to several FDA approvals. He serves as an advisor to several regulatory agencies, including the FDA.