Quality control of biologicals produced by recombinant DNA techniques. WHO consultation.

The efforts now being made in the pharmaceutical industry to apply recombinant DNA techniques to the large-scale production of medically useful biologicals require that procedures be developed for the standardization and control of these products. These procedures will need to test the identity, purity, and stability of the plasmid, the reliability of the procedure used in the preparation of the seed clone of bacteria, and all intermediate and final products. In many cases, new techniques will have to be developed for this testing. Some of the factors will be safeguarded by inprocess control, but great reliance will be placed on tests of the final product. The present article outlines the tests that would be appropriate for the control of the safety and efficacy of recombinant DNA products; it is aimed mainly at scientists and administrators in countries not involved in the production of such biologicals, to inform them of the problems involved in their control.