Implementing advanced production platform strategies to achieve a high producing process when moving from early to late stage development often requires changing media platforms, cell-culture process parameters, and the cell line. These changes can lead to variations in product quality that need to be understood and controlled. In this case-study, the early stage cell culture process utilized peptone-containing media whereas the late stage cell culture process used chemically-defined media (CDM). The use of CDM reduces or eliminates some of the risks associated with the use of peptone-containing media, including inconsistent performance due to lot-to-lot variability, potential introduction of adventitious agents, and raw material sourcing. In the example presented here, a highly productive, robust late stage process with nearly a three-fold increase in titer (compared to the early stage process) was developed but yielded differences in charge variants, size variants, and the glycosylation pattern. Comparability to the early stage product was achieved by adjusting the media components and process parameters.

Challenges associated when moving from a peptone-containing early stage cell culture process to a chemically-defined late stage cell culture process<br />

249th National Meeting (2015)

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