Assessing Protein Content and Dimer Formation in the Bevacizumab Reference Product and Biosimilar Versions Marketed in Spain

Assessing Protein Content and Dimer Formation in the Bevacizumab Reference Product and Biosimilar Versions Marketed in Spain

Background: The manufacture of biologics is a complex, controlled, and reproducible process that results in a product that meets specifications. This should be based on data from batches used to demonstrate manufacturing consistency. Ten batches of originator product (Avastin<sup>®</sup>...

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Bibliographic Details
Main Authors: Alexis Oliva, Magdalena Echezarreta, Álvaro Santana-Mayor, Adrían Conde-Díaz, Joao Goncalves, Shein-Chung Chow, Matías Llabrés
Format: Article
Language:English
Published: MDPI AG 2024-11-01
Series:Pharmaceutics
Subjects:
bevacizumab
biosimilar
analytical similarity
quality range method
between- and within-batch variability
Online Access:https://www.mdpi.com/1999-4923/16/12/1520
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