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Recommendations to optimize detection of host antibodies presented.
2004 OCT 6 - (NewsRx.com & NewsRx.net) -- Researchers provide recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products.
"Most biopharmaceutical therapeutics elicit some level of antibody response against the product. This antibody response can, in some cases, lead to potentially serious side effects and/or loss of efficacy. Therefore, the immunogenicity of therapeutic proteins is a concern for clinicians, manufacturers, and regulatory agencies. In order to assess immunogenicity of these molecules, appropriate detection, quantitation, and characterization of antibody responses are necessary," scientists in the United States report.
"Inadequately designed antibody assays have led to the hampering of product development or, during licensure, post-marketing commitments," said Anthony R. Miresluis at the U.S. Food and Drug Administration and collaborators throughout the U.S. "This document provides scientific recommendations based on the experience of the authors for the development of anti-product antibody immunoassays intended for preclinical or clinical studies."
"While the main focus of this document is assay design considerations, we provide scientific focus ...
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Source: HighBeam Research, Recommendations to optimize detection of host antibodies presented.