Handbook of Biological Therapeutic Proteins

ISBN-13: 9781032489605 / Twarda / 2024 / 408 str.

USA) Niazi Sarfaraz (PharmSci Inc.

Opis

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.

Spis treści

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

O autorze

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.