title: Considerations for the development of therapeutic monoclonal antibodies.
abstract: An increasing number of Investigational New Drug (IND) applications for therapeutic monoclonal antibodies (mAbs) have been submitted to US FDA over the past several years. Monoclonal antibodies and related products are under development for a wide range of indications. In addition, the diversity of antibody-related products is increasing including IgG2/IgG4 subclasses and engineered Fc regions to enhance or reduce antibody effector functionality. Recent findings highlight the need to more fully characterize these products and their activity. Advances in product characterization tools, immunogenicity assessments, and other bioanalytical assays can be used to better understand product performance and facilitate development.
authors.affiliation: Division of Monoclonal Antibodies, Center for Drugs Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA. patrick.swann@fda.hhs.gov
authors.forename: Patrick G
authors.initials: PG
authors.lastname: Swann
authors.forename: Mate
authors.initials: M
authors.lastname: Tolnay
authors.forename: Subramanian
authors.initials: S
authors.lastname: Muthukkumar
authors.forename: Marjorie A
authors.initials: MA
authors.lastname: Shapiro
authors.forename: Barbara L
authors.initials: BL
authors.lastname: Rellahan
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Clouse
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use*; D016207:Cytokines / Q000378:metabolism; D006801:Humans; D007141:Immunoglobulin Fc Fragments / Q000276:immunology* / Q000627:therapeutic use; D007132:Immunoglobulin Isotypes / Q000276:immunology* / Q000627:therapeutic use; D015202:Protein Engineering
chemical_list: D000911:Antibodies, Monoclonal; D016207:Cytokines; D007141:Immunoglobulin Fc Fragments; D007132:Immunoglobulin Isotypes