Medicines from New Biotechnologies

Griffiths E. The control of biological medicinal products produced by recombinant DNA technology. Dev Biol Stand 1985; 59: 155–9

Office of Biologics, Research and Review. Points to consider in the manufacture and testing of monoclonal antibody products for human use. Bethesda: Food and Drug Administration, 1987

Office of Biologics, Research and Review. Points to consider in the production and testing of new drugs and biologicals produced by recombinant DNA technology. Bethesda: Food and Drug Administration, 1987

World Health Organization. Quality control of biologicals produced by recombinant DNA techniques. Bull WHO 1983; 61: 897–911

World Health Organization. Acceptability of cell substrates for production of biologicals. WHO Tech Rep Ser 1987; 747: 3–29

Commission of the European Communities. Notes to applicants for marketing authorizations on the production and quality control of monoclonal antibodies of murine origin intended for use in man. III/859/86-EN, June 1987

Commission of the European Communities. Notes to applicants for marketing authorizations on the production and quality control of medicinal products derived by recombinant DNA technology. III/860/86-EN, June 1987