During the recent monthly meeting for the PK assay working group, Dr. Keyang Xu from Genetech/Roache presented valuable insights into the strategy and practices of utilizing Immunoaffinity LC-MS for measuring protein therapeutics and biomarkers. The following key take-home messages were highlighted:
- Immunoaffinity capture LC-MS offers a reliable and effective alternative to LBA (ligand-binding assays) in the bioanalysis of protein drugs and targets.
- Understanding which analyte(s) to measure is crucial, considering factors such as the impact of biotransformation on the results.
- Bioanalytical assay strategies can encompass both generic and specific approaches, catering to the unique requirements of the study.
- Starting with LBA acceptance criteria is recommended as a solid foundation for assay development, validation, and sample analysis.
The monthly gathering of the PK Assay Working Group, focusing on PK Methodologies for Biologics, Cell, and Gene therapies, provides an invaluable platform for industry experts to come together. During these meetings, we collaboratively share best practices, tackle emerging challenges, and exchange valuable experiences. The primary goal is to support each other in refining PK methodologies and facilitating successful filling and submission processes.
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Mark Ma Ph.D.
Head of Translational Clinical Sciences
Rallybio
New Haven CT
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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