<i>As with many other organizations Amgen has made significant advances towards the standardization of the tech transfer business process to ensure successful and consistent performance between sending and receiving sites, in particular for antibody based fed batch processes. Today however, the growing diversity of pipeline molecules resulting from a biology first, modality independent approach that leverages multiple manufacturing technology options has led to new unknowns and challenges, in particular, new sources of process-input variation. This presentation will describe the application of prior lessons learned to new modalities and intensified processes. This presentation will also review the challenges associated with new materials and process technologies. Approaches for the systematic assessment of development data, prior platform knowledge and manufacturing process data will be presented as a means to manage and overcome these challenges. </i><br/>

Tech transfer: The challenges and opportunities represented by a rapidly evolving product pipeline and global manufacturing network

255th National Meeting (2018)

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