Assessment of Structural and Functional Comparability of Biosimilar Products: Trastuzumab as a Case Study: S. Joshi, AS Rathore
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S Joshi, AS Rathore
BioDrugs, 2020
Springer
Background 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 acceptable range of the critical quality attributes is defined based on the expected impact of a specific variation on the product stability, safety, and efficacy. For a biosimilar to receive regulatory approval …
