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          Immunogenicity Assessment for Therapeutic Protein ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Immunogenicity Assessment for Therapeutic Protein Products
					
		
		August 2014


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2013-D-0092
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


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.


 
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						All written comments should be identified with this document's docket number: FDA-2013-D-0092.

                                                                                  Content current as of:
      02/22/2018
         
                  
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