Handbook of biological therapeutic proteins : regulatory, manufacturing, testing, and patent issues
Niazi, Sarfaraz, 1949-
"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."
Type of material - book
; adult, serious
Edition - 2nd ed.
Publication and manufacture - Boca Raton (FL) ; Abingdon (UK) : CRC Press, Taylor & Francis Group, cop. 2024
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