title: Advances in the assessment and control of the effector functions of therapeutic antibodies.
abstract: The Fc (crystallizable fragment) region of therapeutic antibodies can have an important role in their safety and efficacy. Although much is known about the structure-activity relationship of antibodies and the factors that influence Fc effector functions, a process has not yet been defined to clearly delineate how Fc functionality should be assessed and controlled during antibody development and manufacturing. In this article, we summarize the current knowledge of antibody Fc functionality, provide a strategy for assessing the effector functions of different classes of therapeutic antibodies (including Fc fusion proteins) and propose a path for routine testing and controls for manufacturers of antibody products.
authors.affiliation: Analytical Biochemistry, MedImmune, Gaithersburg, Maryland 20878, USA. jiangx@medimmune.com
authors.forename: Xu-Rong
authors.initials: XR
authors.lastname: Jiang
authors.forename: An
authors.initials: A
authors.lastname: Song
authors.forename: Svetlana
authors.initials: S
authors.lastname: Bergelson
authors.forename: Thomas
authors.initials: T
authors.lastname: Arroll
authors.forename: Bhavin
authors.initials: B
authors.lastname: Parekh
authors.forename: Kimberly
authors.initials: K
authors.lastname: May
authors.forename: Shan
authors.initials: S
authors.lastname: Chung
authors.forename: Robert
authors.initials: R
authors.lastname: Strouse
authors.forename: Anthony
authors.initials: A
authors.lastname: Mire-Sluis
authors.forename: Mark
authors.initials: M
authors.lastname: Schenerman
mesh_terms: D000818:Animals; D000906:Antibodies / Q000737:chemistry* / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000737:chemistry / Q000627:therapeutic use; D003460:Crystallization; D006801:Humans; D007141:Immunoglobulin Fc Fragments / Q000737:chemistry* / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000737:chemistry / Q000276:immunology / Q000627:therapeutic use
chemical_list: D000906:Antibodies; D000911:Antibodies, Monoclonal; D007141:Immunoglobulin Fc Fragments; D011993:Recombinant Fusion Proteins