Marcus Mreyen
Protagen Protein Services GmbH, Germany
Title: CMC Consideration for Biosimilar Drug Development and Manufacturing Process
Biography
Biography: Marcus Mreyen
Abstract
As more and more blockbuster biologics loose patent protection, hundreds of biosimilar/ follow-on biologics developments have been started by multiple companies internationally and more will follow next years. Matching Biosimilarity is the key for these projects giving a high priority on CMC consideration with new aspects compared to NBE developments like Originator Monitoring to define the QTPP for the upcoming biosimilar and for the subsequent pool and clone selection phase. The analytical characterization and monitoring is crucial to make a quality driven development and to select the most promising candidate on top of aspects productivity, stability and upscaling possibility. Depending on the molecule complex structural characterization, glycosylation and physicochemical analysis with orthogonal techniques is required to demonstrate the biosimilarity to the originator molecule. The presentation will focus on the CMC requirements needed in the different steps of Biosimilar development. In addition different examples will highlight the analytical modules used in each development stage and how they align in a multidisciplinary overall Biosimilar development project.
