Biopharmaceutics and Biologic Drugs

With the advent of Biotechnology more and more human recombinant protein biotherapeutics have replaced the animal derived drug products. Th is has helped in global availability of quality drug products at a competitive price. Th e advantages of the recombinant protein biotherapeutics are high purity, high specifi c activity, steady supply and batch-to-batch consistency. All protein biotherapeutics are potentially immunogenic and hence could elicit immunogenicity response. Th ese responses could be of diff erent types such as binding antibodies or neutralizing antibodies. Immunogenicity of protein biotherapeutics is a major concern especially when the biological function of the drug and the endogenous counterpart are neutralized by antidrug antibodies (ADA). Hence the regulatory agencies insist that the immunogenicity response should be assessed by validated sensitive assay formats during the diff erent stages of drug development and the antibody response be characterized. An effort has been made in this presentation to discuss on immunogenicity to protein biotherapeutics, regulatory concerns, strategy to evaluate the immunogenicity, overview of methods available, factors infl uencing immunogenicity and to share the experience of developing an ADA method using ELISA and GYROS assay format to assess immunogenicity of two drug products