Considerations for the development of therapeutic monoclonal antibodies.
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.
Swann
Patrick G
PG
Division of Monoclonal Antibodies, Center for Drugs Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA. patrick.swann@fda.hhs.gov
Tolnay
Mate
M
Muthukkumar
Subramanian
S
Shapiro
Marjorie A
MA
Rellahan
Barbara L
BL
Clouse
Kathleen A
KA
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
D000911:Antibodies, Monoclonal; D016207:Cytokines; D007141:Immunoglobulin Fc Fragments; D007132:Immunoglobulin Isotypes