Human Anti-Antibody Response

Antibodies are emerging as a new drug class with many of these approved and marketed. Antibodies may be non-human, chimeric, humanized or fully human. All these have the potential to elicit an immune response in the host which may impact on safety and efficacy. Therefore, assessment of immunogenicity of the therapeutic protein is an essential part of its clinical development. This involves testing strategies which provide relevant information on antibody responses. This chapter describes a simple ELISA method to detect human anti-antibody response.