FDA Issues Draft Guidance on Assessing Immunogenicity of Therapeutic Proteins

The Food and Drug Administration Feb. 8 released a draft guidance for industry on how to assess the immunogenicity of therapeutic protein products.

FDA describes the guidance as a “risk-based approach designed to provide investigators with the tools to develop novel protein therapeutics, evaluate the effect of manufacturing changes, and evaluate the potential need for tolerance-inducing protocols when severe consequences result from immunogenicity,” which is the capability of a specific substance to induce an unwanted immune response.

A notice announcing the draft guidance, “ Immunogenicity Assessment for Therapeutic Protein Products,” was published Feb. 11 in the Federal Register (78 ...