![]() GLP level TCR studies can be expensive and time consuming. Precursor Studies that Should be Performed Prior to TCR studies Because regulatory agencies require that the test biologic be the main reagent in TCR studies, there are instances where the test biologic leads to less than ideal staining but still has potent biological activity. A test biologic is developed because it has qualities that can influence the behavior of a biological process, and therefore, may not be the most optimal IHC reagent. Therefore, what is observed on a glass slide may not necessarily reflect what occurs in vivo.Īnother point to consider is that the test biologic may not be the most suitable reagent for IHC. Finally, the process of cutting tissue onto glass section can uncover intracellular epitopes that are not usually exposed in vivo, allowing the test biologic to bind. For targets that are not proteins such as glycolipids, several fixation methods must be tested as stripping of epitopes can occur. However, the fixation or freezing process of tissue can alter the protein folding, thereby affecting recognition of the epitope. 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. When IHC is used to perform TCR studies, the interaction of the antigen and the test biologic is key. 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.
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