Srishti Joshi Author
Subjects of specialization
Affiliation
Analytical Chemistry
Coordinator (Analytical Division), Centre for Biopharmaceutical Technology (DBT-COE), IIT-Delhi
Srishti joshi is currently working as a PDF Coordinator (Analytical Division) at Centre for Biopharmaceutical Technology (DBT-COE), IIT-Delhi. She worked as research assistant at Institute of Fundamental Sciences, Massey University and as a lab supervisor at Massey University.
Short Communication Open Access
Author(s): Srishti Joshi
Biotherapeutics are protein products generated using recombinant DNA technology and manufactured in prokaryotic or eukaryotic cells. It is often said that “the process is the product” and thereby the effect of the manufacturing process is etched on the final product in the form of its heterogeneity. For any biotherapeutic, the suitable range of the critical quality attributes is defined supported the expected impact of a selected variation on the merchandise stability, safety, and efficacy. For a biosimilar to receive regulatory approval, the manufacturer must demonstrate analytical and clinical comparability with the originator product. As this is mandatory, every biosimilar manufacturer performs this exercise for each biosimilar product under development. However, few repo... view moreĀ»