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.

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.