Immunogenicity of Protein Therapeutics 2014

Assessment of immunogenicity for many types of biotherapeutics continues to challenge the industry. Investigators need to know how to develop and validate assays, when to perform them, and how to interpret the results as a meaningful risk assessment before moving into the clinic. The FDA requirement for neutralizing antibody assays is a particular hurdle. In the clinic, investigators need to work out how to deal with interfering drugs and to understand the significance of pre-existing antibodies. This conference will enable the investigator to work out an immunogenicity testing strategy for regulatory success and to ensure that their drug is both safe and efficacious.