Abstract
In the 1950s, only primary cell cultures were acceptable for the production of human biological products. This position was challenged in the late 1960s by human diploid cells (HDCs), and again in the 1980s by continuous cell lines (CCLs). The history of the HDC controversy is reviewed and lessons from that era that are relevant to the use of CCLs are pointed out. It became apparent in the early days of recombinant DNA technology in the 1980s that CCLs were needed for the development of some products. CCL acceptability therefore became more urgent, and several attempts were made to reach a consensus on regulatory issues. In 1986, the World Health Organization convened a Study Group to review the safety issues related to products derived from CCLs. The Study Group made a clear recommendation to pursue CCLs in product development because of the demonstrated capability of modern manufacturing processes to cope with contaminants. Issues such as acceptable levels of cellular DNA in products and the relationship of purity to safety are discussed in the context of the need for regulatory authorities, industry, and the general biomedical community to cooperate in addressing problems in a rational scientific manner.
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References
Beale AJ (1979) Choice of cell substrate for biological products. Advances in Experimental Biology and Medicine 118:83–97.
Hopps HE & Petricciani JC (eds.) (1985) Abnormal Cells, New Products, and Risks. Tissue Culture Association, Gaithersburg.
Hull RN (1968) Immunization of experimental animals with vaccines produced in known oncogenic cells. National Cancer Institute Monograph (USA) 29:503–509.
National Cancer Institute Monograph (USA) (1968) Vol. 29.
Petricciani JC, Hopps HE & Chapple PJ (eds.) (1979) Cell Substrates. Plenum, New York.
Petricciani JC and Hennessen W (eds.) (1987) Cells, Products, Safety: background papers for the WHO Study Group on Biologicals. Developments in Biological Standardization, Vol. 68.
Petricciani JC (1989) Cells, science, and health. Developments in Biological Standardization 70:3–10.
Regan PJ & Petricciani JC (1987) The approach used to establish the safety of veterinary vaccines produced in the BHK-21 cell line. Developments in Biological Standardization 68:19–25.
Report of the meeting of the study group on biologicals (1987) WHO Technical Report Series, No. 747.
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Petricciani, J.C. The acceptability of continuous cell lines: A personal & historical perspective. Cytotechnology 18, 9–13 (1995). https://doi.org/10.1007/BF00744314
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DOI: https://doi.org/10.1007/BF00744314