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.

List of contents

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

About the author

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.

Product details

• Authors: Sarfaraz Niazi, Sarfaraz (Pharmaceutical Scientist Inc. Niazi
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Paperback / Softback
• Released: 29.08.2025
• EAN: 9781032490540
• ISBN: 978-1-0-3249054-0
• No. of pages: 408
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Non-clinical medicine; SCIENCE / Chemistry / General, MEDICAL / Pharmacology, MEDICAL / Biochemistry, biochemistry, Pharmacology, Pharmaceutical technology, Pharmaceutical chemistry and technology