Júlia Anna Láng, Zsófia Cselovszkiné Balogh, Mónika Fizilné Nyitrai, Cintia Juhász, Anna Katalin Baráné Gilicze, Attila Iliás, Zsolt Zólyomi, Csaba Bodor, Erzsébet Rábai
The key factor in successful development and marketing of biosimilar antibodies is a deep understanding of their critical quality attributes and the ability to control them. Comprehensive functional characterization is therefore at the heart of the process and is a crucial part of regulatory requirements. Establishment of a scientifically sound molecule-specific functional in vitro assay panel requires diligent planning and high flexibility in order to respond to both regulatory requirements and the ever-changing demands relevant to the different stages of the development and production process...
December 2020: Drug Discovery Today. Technologies