Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues

— —

Sarfaraz Niazi (Pharmaceutical Scientist Inc., Deerfield, Illinois, USA)

Handbook of Biogeneric Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

Sarfaraz Niazi (Pharmaceutical Scientist Inc., Deerfield, Illinois, USA)

$164.95 $131.96

Paperback

Not in-store but you can order this
How long will it take?

Availability Information

We source books from suppliers in Australia and overseas. For books we don't currently have in stock, the time it takes to get them from our suppliers can vary widely - from a few days to a few months - so we check each book with each supplier to determine the expected time it will take to be supplied to us.

We then advise you accordingly. If the time taken to get any book is too long for you, you can let us know and we will cancel or adjust your order, and refund as required.

To find out the anticipated arrival time for specific items prior to ordering, please contact us by phone or email:

Phone +61 2 9264 3111, or 1800 4 BOOKS (1800 4 26657) if outside Sydney:
option 1 Abbey's Bookshop (Crime, History, Science, Kids & more) • info@abbeys.com.au
option 2 Language Book Centre (ESL & Foreign Languages) • language@abbeys.com.au
option 3 Galaxy Bookshop (Sci-fi, Fantasy, Romance, Graphic Novels) • sf@galaxybooks.com.au

QTY:

English

CRC Press
29 August 2025

Pharmacology; Biochemistry; Pharmaceutical technology

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.

By: Sarfaraz Niazi (Pharmaceutical Scientist Inc. Deerfield Illinois USA)
Imprint: CRC Press
Country of Publication: United Kingdom
Edition: 2nd edition
Dimensions: Height: 254mm, Width: 178mm,
Weight: 750g
ISBN: 9781032490540
ISBN 10: 1032490543
Pages: 408
Publication Date: 29 August 2025
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

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.