References can be made to other sections of the application for more detailed process information. 3. Detailed Description a. Animal Sources Detailed guidance in this area may be obtained from the Draft Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use...
regardingvirustestingandmycoplasmatesting,thePointstoConsiderinthe CharacterizationofCellLinesUsedtoProduceBiologicals(1993),shouldbe consulted. 4.Monitoringofcellidentityandheterogeneity:Bothmanufacturingandtesting proceduresshouldbeimplementedwhichensurethecontrolofcellcultureswith regardtoidentityandheterogeneity. Cellcultu...
Guidance for Industry Guidance for Human Somatic Cell Therapy and Gene Therapy Comments and suggestions regarding this document may be submitted at anytime to Dano B. Murphy, HFM-17, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852...
2 B. How is this Guidance Organized? 2 II. ADMINISTRATIVE INFORMATION TO BE DOCUMENTED BY FDA REVIEWERS 3 III. PRODUCT MANUFACTURING AND CHARACTERIZATION INFORMATION TO BE SUBMITTED BY SPONSORS AND DOCUMENTED BY FDA REVIEWERS 4 A. Product Manufacturing – Components and Materials 4 1. Cells 4 2...