2nd Edition

Handbook of Biological Therapeutic Proteins Regulatory, Manufacturing, Testing, and Patent Issues

By Sarfaraz Niazi Copyright 2024
    412 Pages 39 Color & 18 B/W Illustrations
    by CRC Press

    412 Pages 39 Color & 18 B/W Illustrations
    by CRC Press

    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.


    • 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


    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.