The methodological development is carried out in accordance with GLP standards and the Technical Guidelines for Drug Immunogenicity Research. The detection adopts a multi-level strategy, which sequentially conducts screening tests, confirmation tests, and if necessary, titer tests and/or neutralization activity tests on confirmed positive samples. We have established detection methods for various macromolecular drugs such as peptides, short peptides, monoclonal antibodies, and conjugated antibodies. There is an in vitro cytokine release detection platform, which uses human whole blood or human peripheral blood mononuclear cells for in vitro evaluation.