Protein based therapeutics may elicit unwanted immune responses that produce neutralizing or nonneutralizing antitherapeutic antibodies (ATA) in patients. These antibodies often impact drug pharmacokinetics, clinical efficacy, and patient safety. Therefore, it is critical to detect antibody response and characterize ATA in both preclinical and clinical phase of development to assess immunogenicity risks. It is also important to study the triggers and causes of immunogenicity as well as predict immunogenicity in order to reduce the potential for immunogenicity during drug development. We invite authors to submit original research as well as review articles.

Potential topics include, but are not limited to:

• Novel methods in immunogenicity testing and ATA characterization (i.e., neutralizing ability, domain mapping, ATA isotyping, and preexisting ATA) for preclinical and clinical studies
• Study the underlying mechanism of antibody response and identify critical contributing factors (i.e., protein aggregation, impurity, and posttranslational modifications including glycosylation) related to biologics or patients
• Animal models, in silico and in vitro assay systems that predict the immunogenicity of biologics
• Challenges presented by molecular engineered features of biologics that affect or induce immunogenicity
• Enhanced understanding of the impact of the ATA on study outcomes (i.e., PKPD, efficacy, and safety)