Unwanted immunogenicity: Implications for follow-on biologicals

作者：Wadhwa Meenu^*; Thorpe Robin

来源：Drug Information Journal, 2007, 41(1): 1-10.

• antibodies
• neutralizing
• assays
• prediction
• strategy

The unexpected and unpredictable development Of unwanted immunogenicity is a significant issue affecting therapeutic proteins, including follow-on biologicals. The development of antibodies against the therapeutic biological can cause allergic or anaphylactic reactions, reduction in efficacy, and, in some cases, severe adverse effects. The risk of inducing immune responses is largely dependent on the recipient as well as a number of product-related factors (eg, production process, formulation, and number of doses administered during the course of treatment). Consideration should be given to the evaluation of unwanted immunogenicity of follow-on biologicals from preclinical development, through clinical trials, and into the postregistration period to minimize the risks associated with immunogenicity in recipients of therapeutic products. Properly planned immunogenicity studies during phase IIII clinical trials using a range of carefully validated procedures are needed to assess unwanted immunogenicity of therapeutic products.

• 出版日期2007