Therapeutic Product Immunogenicity Community

Dear network

Here is a Thursday challenge. This concerns developing an analytical strategy for a compound that has an endogenous counterpart with a different spectrum of activity. So far, we have been focusing on detecting and characterizing antibodies against the experimental drug, but do we need to implement a parallel track to capture and characterize antibodies that cross-reacts with the endogenous counterpart? These would not all be captured by current binding assay and NAb assay............and please, if you have references that discuss this, it would be great :-)

kindly, Per

Dear network

Here is a Thursday challenge. This concerns developing an analytical strategy for a compound that has an endogenous counterpart with a different spectrum of activity. So far, we have been focusing on detecting and characterizing antibodies against the experimental drug, but do we need to implement a parallel track to capture and characterize antibodies that cross-reacts with the endogenous counterpart? These would not all be captured by current binding assay and NAb assay............and please, if you have references that discuss this, it would be great :-)

kindly, Per

Dear network

Here is a Thursday challenge. This concerns developing an analytical strategy for a compound that has an endogenous counterpart with a different spectrum of activity. So far, we have been focusing on detecting and characterizing antibodies against the experimental drug, but do we need to implement a parallel track to capture and characterize antibodies that cross-reacts with the endogenous counterpart? These would not all be captured by current binding assay and NAb assay............and please, if you have references that discuss this, it would be great :-)

kindly, Per

Dear network

Here is a Thursday challenge. This concerns developing an analytical strategy for a compound that has an endogenous counterpart with a different spectrum of activity. So far, we have been focusing on detecting and characterizing antibodies against the experimental drug, but do we need to implement a parallel track to capture and characterize antibodies that cross-reacts with the endogenous counterpart? These would not all be captured by current binding assay and NAb assay............and please, if you have references that discuss this, it would be great :-)

kindly, Per

Hello Per,

I'm also wondering if you have conducted a formal immunogenicity risk assessment and bioanalytical strategy for the program that you have shared with regulators.  In recent conversations with FDA they have indicated that they view the risk assessment as the foundation of the ISI and want to see it included in the IND.  This approach has several advantages as it allows for early engagement and alignment with regulators,  Recently, I have heard industry experts voice the notion that the ISI is required only at filing.  While it is true that it is submitted with the filing, the ISI is a living document that should be updated regularly as your drug moves through development.  

Dear network

Here is a Thursday challenge. This concerns developing an analytical strategy for a compound that has an endogenous counterpart with a different spectrum of activity. So far, we have been focusing on detecting and characterizing antibodies against the experimental drug, but do we need to implement a parallel track to capture and characterize antibodies that cross-reacts with the endogenous counterpart? These would not all be captured by current binding assay and NAb assay............and please, if you have references that discuss this, it would be great :-)

kindly, Per

Dear network

Here is a Thursday challenge. This concerns developing an analytical strategy for a compound that has an endogenous counterpart with a different spectrum of activity. So far, we have been focusing on detecting and characterizing antibodies against the experimental drug, but do we need to implement a parallel track to capture and characterize antibodies that cross-reacts with the endogenous counterpart? These would not all be captured by current binding assay and NAb assay............and please, if you have references that discuss this, it would be great :-)

kindly, Per