Abstract
The original and fundamental appeal of monoclonal antibodies (mAbs), compared with polyclonal antisera, is the possibility for indefinite production of the same product. However, even well-established cell lines have limited stability in long-term culture and it is necessary to establish a control system to ensure continuity of product supply. This is normally done by a seed lot system. A pool of cells derived from a single clone is frozen in a number of vials (say 100) to create a master cell bank (MCB). This MCB is carefully stored in liquid nitrogen. As required, individual vials are thawed and expanded to provide working cell banks, which might also consist of about 100 vials. Thus up to 10,000 production runs can be initiated before the original cell stock is exhausted. Obviously the number of vials in a bank can be adjusted to meet individual requirements. Working cell banks may not be necessary for experimental or preclinical projects, but you should at all costs avoid depletion of a clinically important master cell bank.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Committee for Proprietary Medicinal Products: Ad hoc working party on Biotechnology/Pharmacy (1998) Guidelines on the production and quality control of medicinal products derived by recombinant DNA technology. Trends Biotechnol.6, G1–G4.
Committee for Proprietary Medicinal Products: Ad hoc working party on Biotechnology/Pharmacy (1998) Guidelines on the production and quality control of monoclonal antibodies of murine origin intended for use in man. Trends Biotechnol.6, G5–G8.
Bebbington, C. R., Renner, G., Thomson, S., King, D., Abrams, D., and Yarranton, G. T. (1992) High-level expression of a recombinant antibody from myeloma cells using a glutamine synthetase gene as an amplifiable selectable marker. Bio/Technology10, 169–175.
Bird, P., Bolam, E., Castell, L., Obeid, O., Darton, N., and Hale, G. (1998) Glutamine synthetase transfected cells may avoid selection by releasing glutamine. New developments and new applications in animal cell technology (Merten, O.-W., Perrin, P., and Griffiths, B., eds.) 15th Meeting of the European Society for Animal Cell Technology 1997, Kluwer, Dordrecht, The Netherlands, pp. 43–49.
Assenmacher, M., Schmitz, J., and Radbruch, A. (1994) Flow cytometric determination of cytokines in activated murine T helper lymphocytes: expression of interleukin-10 in interferon-y and in interleukin-4 expressing cells. Eur. J. Immunol.24, 1091–1101.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2000 Humana Press Inc.
About this protocol
Cite this protocol
Bird, P., Hale, G. (2000). Cell Banks and Stability of Antibody Production. In: George, A.J.T., Urch, C.E. (eds) Diagnostic and Therapeutic Antibodies. Methods in Molecular Medicine, vol 40. Humana, Totowa, NJ. https://doi.org/10.1385/1-59259-076-4:303
Download citation
DOI: https://doi.org/10.1385/1-59259-076-4:303
Publisher Name: Humana, Totowa, NJ
Print ISBN: 978-0-89603-798-4
Online ISBN: 978-1-59259-076-6
eBook Packages: Springer Protocols