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          Monoclonal Antibodies Used as Reagents in Drug ManufacturingSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Monoclonal Antibodies Used as Reagents in Drug Manufacturing
					
		
		March 2001


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          Center for Biologics Evaluation and Research


This guidance is intended to provide recommendations to sponsors and applicants on the use of monoclonal antibodies (mAbs) as reagents in the manufacture of drug substances that are regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The guidance focuses on the chemistry, manufacturing, and control (CMC) issues that should be addressed in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), supplements to these applications, or investigational new drug applications (INDs).


 
	Submit Comments
	   		  			  			Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All comments should be identified with the title of the guidance.

                                                                                  Content current as of:
      08/24/2018
         
                  
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