Handbook of Biogeneric Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

Sarfaraz Niazi (Autor)

Buch | Softcover

408 Seiten

2025 | 2nd edition
CRC Press (Verlag)
978-1-032-49054-0 (ISBN)

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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. The newer technologies for development represent the updated topics in the book and include repurposing, AI-driven identification of newer designs, novel expression systems and manufacturing, fast changing regulatory pathways, and legal hurdles. Discusses how to identify, develop, manufacture and take multibillion dollar products to market in 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 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.

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.

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

Erscheinungsdatum	08.03.2024
Zusatzinfo	69 Tables, black and white; 35 Line drawings, color; 17 Line drawings, black and white; 4 Halftones, color; 1 Halftones, black and white; 39 Illustrations, color; 18 Illustrations, black and white
Verlagsort	London
Sprache	englisch
Maße	178 x 254 mm
Gewicht	860 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Medizin / Pharmazie ► Pflege
	Medizin / Pharmazie ► Pharmazie ► PTA / PKA
	Naturwissenschaften ► Biologie ► Biochemie
	Technik
ISBN-10	1-032-49054-3 / 1032490543
ISBN-13	978-1-032-49054-0 / 9781032490540
Zustand	Neuware