Read "A Generic LC-MS/MS Solution for ADC PK Bioanalysis"
ADCs combine the targeting power of monoclonal antibodies with the potency of small-molecule drugs, making them one of the most promising modalities in oncology. However, their complex structures and pharmacological properties present unique challenges in production, characterization, and PK analysis.
At Crystal Bio Solutions, our experts designed and validated a generic LC-MS/MS solution that enables accurate, timely, and reproducible measurement of total antibody, conjugated payload, and free payload. This method provides the sensitivity and specificity required to support ADC development from early non-clinical research through clinical trials.
Developing robust PK assays for ADCs requires overcoming several obstacles:
Tight development timelines for supporting rapid program advancement
Complex LC-MS sample preparation steps that increase variability
The need to validate assay parameters including accuracy, precision, sensitivity, specificity, and stability across multiple analytes (antibody, conjugated payload, free payload)
These challenges highlight the importance of a generic, adaptable solution that can streamline ADC bioanalysis.
Our experts created a workflow capable of simultaneously quantifying total antibodies, conjugated payload, and free payload with high sensitivity and reproducibility. By optimizing sample preparation and LC-MS conditions, we established a method that is both generic—applicable to a wide range of ADCs—and tailored enough to deliver regulatory-ready data.
The fully validated LC-MS/MS solution demonstrated:
High sensitivity and specificity, ensuring reliable detection across analytes
Accuracy and precision meeting regulatory expectations
Robust stability for consistent results in both non-clinical and clinical studies
A workflow adaptable to multiple ADC formats within accelerated timelines
ADCs are among the most complex therapeutic modalities under development today. Without validated PK assays, developers risk delays in understanding exposure, efficacy, and safety. By providing a generic and adaptable LC-MS/MS solution, our team helps streamline ADC bioanalysis, supporting faster decision-making, de-risking clinical programs, and ultimately accelerating delivery of novel therapies to patients.
Key Takeaways
Developed a generic LC-MS/MS workflow for ADC PK bioanalysis
Simultaneous quantification of total antibody, conjugated payload, and free payload
Validated with high sensitivity, accuracy, precision, and stability
Provides a robust, adaptable solution to support both non-clinical and clinical ADC studies