Tissue-Cross Reactivity

PART 2:  What to Consider & How to Prepare for TCR studies Considerations for IHC-based TCR Studies According to FDA guidance in ‘‘Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use’’, frozen tissue is recommended for IHC based TCR studies.  When IHC is used to perform TCR studies, the interaction of the antigen and the test biologic is key.  The recognition of the epitope depends on the linear amino sequence and/or a three-dimensional conformation, which occurs when the protein is folded correctly.  However, the fixation or freezing process of tissue can alter the protein [...]

PART 1:  Why Drug Development Values TCR Studies What are Tissue Cross-Reactivity studies? Tissue cross-reactivity (TCR) studies are screening assays used to identify the specific and non-specific binding of test biologics (i.e. antibodies or antibody-like proteins) in various human or non-human tissues. If human tissues are used, the primary goal is to identify potential off-target, cross-reactive epitopes across a wide range of tissues. If non-human tissues are used, these studies can help identify the most relevant species with a similar target expression profile to human.   These studies are routinely performed by leading drug development companies like Pfizer, Genentech, and Genzyme, [...]