Detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals.

Assessment of the unwanted immunogenicity of therapeutic biologicals in recipients is an important consideration in the evaluation of these medicinal products. Proper planning of immunogenicity studies with appropriately devised strategies is critical if valid and meaningful conclusions concerning the unwanted immunogenicity are to be derived. An essential requisite for such studies is the need for conducting carefully selected and validated procedures. Several techniques are available for detection, characterization and measurement of antibodies elicited in an immune response. These include various formats of immunoassays, surface plasmon resonance and biological assays. None of these assays alone can provide sufficient information on the characteristics of the induced antibodies. A combination of methods is therefore usually necessary for a detailed understanding of the quantity and type(s) of antibodies generated against a therapeutic product. This manuscript considers the benefits and limitations of the various techniques available for antibody detection and outlines a brief strategy for the assessment of unwanted immunogenicity of therapeutic products.