An integrated automated workflow using a LC/MS/MS MAM method for potential monitoring of multiple product quality attributes for cell culture process will be proposed. Initial data from manual analysis of model compound samples from small scale development bioreactors and large scale GMP runs will be presented. Data trending across the duration of the cell culture process will be demonstrated for each quality attribute. Data trending for GMP runs will be compared with those from the development lab runs, to provide insight into process performance during scale up. Product quality trending will also be compared with process parameter trending data, trying to establish potential correlation between product quality and process parameters.<br/><br/>Preliminary data using an aseptic sampling system and an online sample preparation system to integrate an automated workflow from bioreactor to analytical testing will also be presented. Challenges, benefits and future plans to develop a fully integrated automated online MAM workflow for daily multiple product quality monitoring of cell culture process both in the development lab and in a GMP manufacturing facility will be discussed.

Towards the development of an integrated automated online LC/MS/MS Multi-Attribute Method (MAM) workflow for the daily monitoring of multiple product quality attributes during cell culture process

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.