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

by Sarfaraz K. Niazi

Overview

More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato

Product Details

ISBN-13:	9781000611328
Publisher:	CRC Press
Publication date:	08/15/2002
Sold by:	Barnes & Noble
Format:	eBook
Pages:	584
File size:	15 MB
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About the Author

Professor Sarfaraz K. Niazi is the chief executive officer of Pharmaceutical Scientist Inc., a consulting company for the pharmaceutical and biotechnology industry (http://www.pharmsci.com). He is also Foreign Professor at the HEJ Research Institute of Chemistry at Karachi University in Pakistan. Professor Niazi has been involved in the licensing, technology transfer, process development, and turnkey pharmaceutical and therapeutic protein manufacturing operations worldwide. Professor Niazi is also licensed to practice patent law before the U.S. Patent and Trademark office and an inventor with scores of patents on new drugs and drug delivery systems. Professor Niazi has been teaching and conducting research for over 35 years and has authored over 100 research articles and written scores of books in the field of pharmaceutical and biotechnology manufacturing, pharmacokinetics, literature, and poetry. His most recent book, Handbook of Pharmaceutical Manufacturing Formulations , is a six-volume work, the largest of its kind ever published. Professor Niazi lives in Deerfield, Illinois, and Karachi, Pakistan.

Table of Contents

Introduction. Market Opportunities in Biogeneric Therapeutic Proteins. Scientific Issues in Therapeutic Protein Manufacturing. Overview of Therapeutic Protein Manufacturing. Development and Manufacturing of Recombinant DNA Therapeutic Proteins. Development and Manufacturing of Monoclonal Therapeutic Proteins. Regulatory Issues in Therapeutic Protein Filings. Analytical Issues in the Testing of Therapeutic Proteins. Intellectual Property Issues in Developing and Marketing Biogeneric Therapeutic Proteins. Preclinical Development of Therapeutic Proteins. Clinical Evaluation of Therapeutic Proteins. Glossary.