Standardization of antibody preparations for use in immunogenicity studies: a case study using the World Health Organization International Collaborative Study for Islet Cell Antibodies.
The immunogenicity of biological therapeutic products is currently a high profile regulatory and biotechnology industry issue. The immune responses raised against biotechnology products range from the benign, to affecting product efficacy, to those that have serious deleterious clinical impact. The most widely used marker of immunogenicity is the detection and measurement of antibody responses ind