| Literature DB >> 18586093 |
Patrick G Swann1, Mate Tolnay, Subramanian Muthukkumar, Marjorie A Shapiro, Barbara L Rellahan, Kathleen A Clouse.
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.Mesh：
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Year: 2008 PMID： 18586093 DOI： 10.1016/j.coi.2008.05.013
Source DB: PubMed Journal: Curr Opin Immunol ISSN： 0952-7915 Impact factor: 7.486