Minimizing the immunogenicity of protein therapeutics.

As is cautioned in many package inserts, 'with all therapeutic proteins, there is a potential for immunogenicity'. Immunogenicity problems in humans, which currently can be detected only in clinical trials or after product launch, pose a significant barrier to the development and acceptance of protein drugs. Recent and ongoing research, presented in this review, seeks to address the challenge of protein therapeutic immunogenicity by elucidating the mechanisms underlying immune recognition of protein therapeutics, establishing preclinical methods for assessing immunogenicity and developing strategies for minimizing immune responses.