
In the phase 3 SHINE-2 trial, half of pediatric patients who responded to mirikizumab induction were in clinical remission at week 52. Lilly plans to file for a pediatric UC label expansion.
by Harish Iyer, Felicia Henderson, Eric Cunningham, James Welbb, John Hanson, Christopher Bork, and Lynn Conley, IDEC Pharmaceuticals Corporation Scale-up changes in an antibody purification process can increase final product purity, make the process more robust, and reduce processing time. This case study focuses on the initial purification step -- protein A chromatography -- and offers data collected from several years of process development work on many different antibodies.
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