Biosimilars and Interchangeable Biologics: Tactical Elements

Author:   Sarfaraz K. Niazi
Publisher:   Taylor & Francis Inc
ISBN:  

9781498743495


Pages:   624
Publication Date:   23 December 2015
Format:   Hardback
Availability:   In Print   Availability explained
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Biosimilars and Interchangeable Biologics: Tactical Elements


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Author:   Sarfaraz K. Niazi
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Weight:   2.222kg
ISBN:  

9781498743495


ISBN 10:   1498743498
Pages:   624
Publication Date:   23 December 2015
Audience:   General/trade ,  College/higher education ,  Professional and scholarly ,  General ,  Tertiary & Higher Education
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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.

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Author Information

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.

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