Recombinant DNA Technology in Medicine

Examples of the early application of recombinant DNA technology in medicine are the development of recombinant human growth hormone human insulin human interferons, thought to have anticancer activity in addition to antiviral activity interleukins (regulatory proteins from lymphocytes that are believed to be important in the treatment of immunodeficiency diseases and cancer) tumor necrosis factor epidermal and bone marrow progenitor cell growth factors and the production of vaccines (Table 12.1). 

Application of Recombinant DNA Technology in Medicinal Chemistry and Drug Discovery... 

Any medicinal product in the composition of which there is a proteinaceous constituent obtained by means of recombinant DNA technology irrespective of whether or not the constituent is an active substance of the medicinal product. This also appUes where a recombinant DNA technology step is introduced into the manufacture of a proteinaceous product after the granting of a marketing authorisation. 

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). 

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