2nd Edition
Handbook of Biogeneric Therapeutic Proteins Regulatory, Manufacturing, Testing, and Patent Issues
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.
