Description
Anti-Palivizumab ELISA for the quantitative estimation of antibodies to Palivizumab in human serum and plasma. Palivizumab is a humanized monoclonal antibody (IgG1k) that binding the (respiratory syncytial virus) RSV envelope fusion protein (RSV F) on the surface of the virus and blocking a critical step in the membrane fusion process. Palivizumab targets the fusion protein of RSV,[8] inhibiting its entry into the cell and thereby preventing infection. Palivizumab was approved for medical use in 1998. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals. Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Trastuzumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects Anti-Palivizumab antibodies and may be used for monitoring immunogenicity.
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