Biosimilars and Interchangeable Biologics: Tactical Elements, 1st Edition (e-Book) book cover

Biosimilars and Interchangeable Biologics

Tactical Elements, 1st Edition

By Sarfaraz K. Niazi

CRC Press

623 pages

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pub: 2015-12-23
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What's the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set th

Table of Contents

Structural and Functional Elements. Immunogenicity Considerations. Product Development Strategies. Stability and Formulation Considerations. Biosimilarity Tetrahedron. Recombinant Expression Systems. Upstream Systems Optimization. Downstream Systems Optimization. Single-Use Manufacturing Systems (SUMS). Commercial Manufacturing Overview. Outsourcing Considerations. Appendix: Glossary of Terms.

About the Author

Sarfaraz K. Niazi, PhD, is the founding executive chairman of Therapeutic Proteins International LLC, a world-class pure-play developer and manufacturer of biosimilar and interchangeable recombinant biologics, headquartered in Chicago. Dr. Niazi began his career teaching pharmacy at the University of Illinois (1972-1988), where he became a tenured professor. He then entered the pharmaceutical industry at Abbott International, becoming a Volwiler Fellow. He left Abbott in 1995 with a passion for making high-cost biological drugs affordable. Dr. Niazi set up several ex-U.S. biosimilar companies and, in 2003, established Therapeutic Proteins International, the only U.S. integrated company of its kind to date.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Biotechnology
MEDICAL / Pharmacology
SCIENCE / Biotechnology