Efficient Upstream Process Development Programs Generated Using Early Molecule Assessment and Culture of Continuous Improvement

To meet the tight timelines required for biopharmaceutical development Amgen has put considerable focus on improving the efficiency of upstream process development. These efficiencies begin with extensive analysis of protein expression and product quality at the molecule selection stage. This is followed with disciplined application of process platforms for clinical manufacturing. The results of this effort have resulted in processes that consistently produce commercial ready cell lines that meet aggressive clinical and commercial requirements.