Issue Date: August 14, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Clinical – Medical, Pharmaceutical Quality
Status: Final
Immunogenicity Assessment for Therapeutic Protein Products
This guidance is intended to assist manufacturers and clinical investigators involved in the development of therapeutic protein products for human use. In this document, FDA outlines and recommends adoption of a risk-based approach to evaluating and mitigating immune responses to or adverse immunologically related responses associated with therapeutic protein products that affect their safety and efficacy. Any given approach to assessing and mitigating immunogenicity is determined on a case-by-case basis and should take into consideration the risk assessment we describe. For the purposes of this guidance, immunogenicity is defined as the propensity of the therapeutic protein product to generate immune responses to itself and to related proteins or to induce immunologically related adverse clinical events.
Download the Guidance Document
