Overcoming iCIEF Method Development Challenges for Complex Biotherapeutics
- A systematic iCIEF method development case study for a complex ADC-related biotherapeutic was presented, demonstrating why conventional "platform" charge-variant methods often fail.Innovation in critical reagents such as carrier ampholytes and detection are helpful for better resolution of charge variants
- A fit-for-purpose platform-like method development approach is proposed for complex biotherapeutics to both facilitate development timeline and ensure sufficient method performance during early phase development