Cells, science and health.

The initial discussions and decisions in 1954 on the use of various types of mammalian cell substrates for the production of human biological products set the stage for controversy in the late 1960's and again in the 1980's when "abnormal" cell substrates were proposed as alternates for primary cell cultures. In the 1960's the issue was human diploid cells, and in the 1980's it has been the use of continuous cell lines. The parallels between the two issues have been obvious to all who have been interested in the subject. The history of the human diploid cell controversy is reviewed from a personal point of view, and lessons from that era that are relevant to the use of continuous cell lines are pointed out. Pragmatism based on the perceived need for human interferon in the late 1970's led to the exploration of human lymphoblastoid cells as substrates. That bold venture into a prohibited zone set the stage for a reconsideration of the acceptability of continuous cell lines as substrates for the production of a wide range of human biologicals. With the introduction of recombinant DNA technology in the 1980's and the potential usefulness of continuous cell lines in product development, the issue of acceptability took on a more acute aspect and several attempts were made to reach a consensus and a resolution of regulatory issues. In 1986 the World Health Organization identified the use of continuous cell lines as of sufficient global importance to convene a Study Group to review the safety issues and to make recommendations on their use, especially for vaccines. The result of that international effort was a clear recommendation to pursue the use of continuous cell lines in product development because of the demonstrated capability of modern manufacturing processes to cope with even theoretically worrying contaminants.(ABSTRACT TRUNCATED AT 250 WORDS)