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Development of JSL for ADA cut point determination in immunogenicity research (2022-KR-30MP-1290)

mingyu oh Celltrion

 

Immunogenicity means that a foreign substance, such as an antigen, elicits an immune response in the body of a human or other animal. Immunogenicity can cause clinical effects such as PK (Pharmacokinetics), Efficacy, and Safety. FDA/EMA regulatory agencies also recommend submitting data on immunogenicity measurement methods. Therefore, in order to successfully develop a therapeutic agent, an assay development strategy for detecting and measuring the immune response is essential, and setting a statistically appropriate cut point in the ADA test method ensures acceptable sensitivity of the test for detecting ADA. plays an important role in The test method mainly uses a tiered approach in which screening assay and confirmation assay are performed sequentially. We will introduce a JSL Script developed to output cut point estimates and results for each step in a single Report by configuring a general blood sample dataset as an example.Breakout