CMC Challenges in the Development of TR1901- ADC, a Bi-specific ADC Targeting CD138 & FGFR3

Time: 11:00 am
day: Track C - Day 2 AM


  • Mitigation of reversible self-association of bispecific mAb and of reduction of blocked engineered cysteines during cell culture harvest were key to developing a successful mAb process
  • Understanding the process changes required to minimise formation of visible particulates during fill
  • Successful mAb production, conjugation, and fill processes were developed and a clinical manufacturing campaign was successfully executed