Abstract
Cell culture engineering has enabled the commercial marketing of about a dozen human therapeutic products derived from rDNA technology and numerous monoclonal antibody products as well. A variety of technologies have proven useful in bringing products to the marketplace. Comparisons of the technologies available 15 years ago are contrasted with those available today. A number of improvements in unit operations have greatly improved the robustness of the processes during the past 15 years. Further evolution of the technology is expected in several directions driven by commercial and regulatory pressures. Some problems remain for the next generation of cell culture engineers to solve.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Bruce ME, Will RG, Ironside JW, McConnell I, Drummond D, Suttie A, McArdle L, Chree A, Hope J, Birkett C, Cousens S, Fraser H and Bostock CJ (1997) Transmission to mice indicate that ‘new variant’ CJD is caused by the BSE agent. Nature 389: 498-501.
Burstyn DG (1996) Contamination of genetically engineered Chinese Hamster Ovary cells. Dev Biol Standard 88: 199-203.
Curran JW, Morgan WM, Hardy AM, Jaffe HW, Darrow WW and Dowdle WR (1985) The epidemiology of AIDS: current status and future prospects. Science 229: 1352-1357.
Garnick RL (1996) Experience with viral contamination in cell culture. Dev Biol Standard 88: 49-56.
Hill AF, Desbruslais M, Joiner S, Sidle KCL, Gowland I, Collings J, Doey LJ and Lantos P (1997) The same prion strain causes vCJD and BSE. Nature 389: 448-450.
Hopps HE (1985) Cell substrate issues - A historical perspective, In: Hopps HE and Petricciani JC (eds.) Abnormal Cells, New Products, and Risk Tissue Culture Association, Gaithersburg, pp. 13-17.
Lubiniecki AS (1987) Safety considerations for cell culture-derived biologicals, In: Lydersen BK (ed.) Large Scale Cell Culture, Carl Hanser, Munich, pp. 231-247.
Lubiniecki AS (1997) Potential influence of international harmonization of pharmaceutical regulations on biopharmaceutical development. Curr Opin Biotechnology 8: 350-356.
Lubiniecki AS and Lupker JH (1994) Purified protein products of rDNA technology expressed in animal cell culture. Biologicals 22: 161-169.
Miller HI (1995) In: Lubiniecki AS and Vargo SA (eds.) Regulatory Practice for Biopharmaceutical Production, Wiley-Liss, New York, pp. 13-32.
Parkman PD (1996) Safety of biopharmaceuticals: a current perspective. Dev Biol Standard 88: 5-7.
Petricciani JC (1985) Regulatory considerations for products derived from the new biotechnology. Pharmaceutical Manufacturing 9: 31-34.
Petricciani JC and Regan PJ (1986) Risk of neoplastic transformation from cellular DNA: Calculations using the oncogene model. Dev Biol Standard 68: 43-49.
Will RG, Ironside JW, Zeidler M, Cousens SN, Estibeiro K and Alperovitch A (1996) A new variant of CJD in the UK, Lancet 347: 921-925
WHO Expert Committee on Biological Standardization, 47th Report, World Health Organization, Geneva.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Lubiniecki, A.S. Historical reflections on cell culture engineering. Cytotechnology 28, 139–145 (1998). https://doi.org/10.1023/A:1008094017583
Issue Date:
DOI: https://doi.org/10.1023/A:1008094017583