2nd Edition
Handbook of Biological Therapeutic Proteins Regulatory, Manufacturing, Testing, and Patent Issues
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.
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-based biopharmaceutical 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
Chapter 1 Biosimilar Biopharmaceuticals
Chapter 2 Regulatory Requirements
Chapter 3 Development Master Plan
Chapter 4 Trends in Recombinant Proteins Manufacturing
Chapter 5 Analytical Assessment
Chapter 6 Clinical Pharmacology Assessment
Chapter 7 Clinical Immunogenicity Assessment
Chapter 8 Clinical Efficacy Assessment
Chapter 9 Recombinant Manufacturing System
Chapter 10 Upstream Processing
Chapter 11 Downstream Process
Chapter 12 Formulation of Biopharmaceuticals
Chapter 13 Quality and Compliance Systems
Chapter 14 Intellectual Property Issues for Scientists
Chapter 15 Advances in Biomanufacturing
Biography
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.
