This poster will highlight the dramatic upstream improvements for an in-licensed monoclonal antibody program under significantly accelerated timelines. The initial process using chemically defined media had a titer around 0.5 g/L for GMP production, a significant drop compared to the performance at bench scale and insufficient to meet the high clinical demand.  In four months, the process development team transferred the process to an internal development facility, re-optimized the process to double the titer, confirmed process performance at pilot scale, and successfully transferred an improved process to multiple GMP facilities for clinical resupply.  In order to meet further clinical demands, a new cell line and process was developed, which after several rounds of optimization resulted in a fed batch process yielding 10 g/L titer using chemically defined media.  This process was successfully scaled up to 500 L.  All the accomplishments were achieved by seamless collaboration with different functions within the development teams, as well as the internal and external GMP manufacturing sites.<br/>

From 0.5 g/L to 10 g/L: A collective effort to improve upstream production for a fast-track program

255th National Meeting (2018)

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