Developing an On-Column Capping Approach to Reduce Charge Heterogeneity of THIOMAB ADCs

• Highlighting two examples of mAb intermediates with high charge heterogeneity, raising regulatory concerns
• Developing on-column capping approach to mask engineered thiols under redox conditions and reduce capping heterogeneity
• Expanding universal implementation of capping approach to reduce ADC analytical complexity and improve process control 

Speakers:

Kai Ni

Staff Engineer, Biotherapeutics Process Development

Takeda Pharmaceutical