Monoclonal Antibody classes

Ia+ Murine class II major histocompatibility complex antigen IB4 Anti-CD 18 monoclonal antibody IBD Inflammatory bowel disease IBMX 3-isobutyl-l-methylxanthine IBS Inflammatory bowel syndrome iC3 Inactivated C3 iC4 Inactivated C4 IC50 Concentration producing 50% inhibition... 

Shirai, K. et al., A monoclonal antibody, DL 10, which recognizes a sugar moeity of MHC class I antigens expressed on NK cells, NK+ T cells, and granulocytes in humans, J. Clin. Immunol., 17, 510, 1997. 

Country of origin Cuba Class Humanized murine IgG2a monoclonal antibody R3... 

N. Delaunay, V. Pichon and M.C. Hennion, Experimental comparison of three monoclonal antibodies for the class-selective immunoextraction of triazines. Correlation with molecular modeling and principal component analysis studies. J. Chromatogr.A 999 (2003) 3-15. 

Whole proteins, including monoclonal antibodies, are the fastest-growing class of therapeutics. Compared with traditional small molecule drugs, much additional analysis is necessary for their development and production due to their large size and complex structure. The protein construct and its formulation have to be optimized during development, and its structural integrity must be closely monitored during production. 

The present guidance does not lay down detailed requirements for specific classes of biological products, and attention is therefore directed to other guidelines issued by the Committee for Proprietary Medicinal Products (CPMP), e.g. the note for guidance on monoclonal antibodies and the note for guidance on products of recombinant DNA technology The Rules Governing Medicinal Products in the European Community, Volume III). 

In 1996, about 10 years after the introduction of the first recombinant DNA product for human use, the FDA modified and streamlined the approval process for biotechnology products considered to be well characterized. These modifications, in essence, established the direction of how biologic macromolecules are researched and developed today in biotechnology-based and traditional pharmaceutical companies [2]. Well-characterized biotechnology products include (1) synthetic peptides consisting of fewer than 20 amino acids, (2) monoclonal antibodies and derivatives, and (3) recombinant DNA-derived products. Anticipating future developments, the FDA is also prepared to consider DNA plasmid products as well-characterized when the first medicinal in this class is submitted for approval. CBER now approves well-characterized biopharmaceuticals under the BLA process [3]. 

Immune responses also may be mounted against therapeutic monoclonal antibodies. The class of monoclonal antibody as well as the animal species from which the distinguishing amino acid sequences of antibody are derived strongly influence immunogenicity. Suffice to say that mouse antibodies, monoclonal or poly-... 

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