Great topic! One point I like to emphasize is the value of adding a true internal standard that can capture impact of all processing steps. This is particularly important when considering the impact of potential interfering substances such as target and anti-drug antibodies. A peptide alone will not capture this. Fortunately, I have seen increased emphasis on the use of appropriate internal standards in recent AAPS work.
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Joleen White Ph.D.
AAPS 2023 Global Health Community Past Chair
Bioanalytical 101 Course Development
Head of Bioassay Development
Gates Medical Research Institute
Cambridge MA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 07-31-2023 13:41
From: Mark Ma
Subject: Immunoaffinity LC-MS for measuring protein therapeutics and biomarkers
During the recent monthly PK assay working group meeting, Dr. Keyang Xu from Genentech/Roche 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 PK Assay Working Group gathering, 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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