A versatile analytical approach to cleaning validation for multiple linker-payload ADC platforms
As antibody-drug conjugate (ADC) pipelines expand, the need for highly sensitive and reliable analytical strategies becomes increasingly critical.
In this whitepaper, our scientists Seokho Hong, Jina Kang, and Minwoo Nam present a versatile analytical approach to cleaning validation for multiple linker-payload ADC platforms, where highly potent cytotoxic payloads must be controlled at trace levels.
Key highlights:
Establishment of meaningful acceptance criteria through highly sensitive analytical methods, supporting lifecycle management
Two case studies on Samsung Biologics’ cleaning method development for residual linker-payload
Achievement of LOQ and LOD values exceeding sensitivity targets, enabling detection well below typical ADC residual acceptance limits
As antibody-drug conjugate (ADC) pipelines expand, the need for highly sensitive and reliable analytical strategies becomes increasingly critical.
In this whitepaper, our scientists Seokho Hong, Jina Kang, and Minwoo Nam present a versatile analytical approach to cleaning validation for multiple linker-payload ADC platforms, where highly potent cytotoxic payloads must be controlled at trace levels.
Key highlights:
- Establishment of meaningful acceptance criteria through highly sensitive analytical methods, supporting lifecycle management
- Two case studies on Samsung Biologics’ cleaning method development for residual linker-payload
- Achievement of LOQ and LOD values exceeding sensitivity targets, enabling detection well below typical ADC residual acceptance limits
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