Published in Medical Letter on the CDC and FDA, October 10th, 2004
"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...
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