In the October meeting of the PK Methodology Working Group, Emma Liu from Genentech led the discussion on Bioanalytical strategy and challenges for PEGylated drug development with a focus on the following areas:
· PK assay (for active drug component-protein portion) challenges due to the heterogeneity of the PEGylated drug material and assay format selection
o Bioanalytical requirements and assay sensitivity
o A case was reviewed by comparing the results from ligand binding assay vs. LC-MS/MS
· The needs and technical solutions to determine the PEG concentrations for safety assessment.
· Technical approaches, including assay buffer selection, for method development and optimization.
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.
VP. 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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