〈129〉 Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies

This chapter provides analytical procedures for murine, chimeric, and humanized IgG isotype monoclonal antibodies and subtypes (e.g., IgG1 and IgG2). Subclasses show differences in amino acid sequence and in the number of disulfide bonds, and in some cases they require subclass-specific analysis. This chapter applies to monoclonal antibodies for therapeutic and prophylactic use and for use as in vivo diagnostics. It does not apply to monoclonal antibodies used as reagents in the manufacture of medicinal products, for which applicable requirements are determined by the appropriate regulatory agency.

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