Guidance on Good Cell Culture Practice

Hartung T. , & Gstraunthaler G. (2000). The standardisation of cell culture procedures. In Progress in the Reduction, Refinement and Replacement of Animal Experimentation (ed. Balls M. , van Zeller A-M. , & Halder M.E. ), pp. 1655–1658. Amsterdam, The Netherlands: Elsevier.

Hartung T. , Gstraunthaler G. , & Balls M. (2000). Bologna Statement on Good Cell Culture Practice (GCCP). ALTEX 17, 38–39.

Hartung T. , Balls M. , Bardouille C. , Blanck O. , Coecke S. , Gstraunthaler G. , & Lewis D. (2002). Good Cell Culture Practices. ATLA 30, 407–414.

OECD (2004). Draft Advisory Document of the OECD Working Group on GLP on the Application of GLP Principles to In Vitro Studies, 18 pp. Paris, France: OECD.

Schaeffer W.I. (1990). Terminology associated with cell, tissue and organ culture, molecular biology and molecular genetics. In Vitro Cellular and Developmental Biology 26, 97–101.

Freshney R.I. (2000). Culture of Animal Cells. A Manual of Basic Technique; 4th edn, 486 pp. New York, NY, USA: Wiley-Liss.

Doblhoff-Dier O. , & Stacey G. (2000). Cell lines: applications and biosafety. In Biological Safety — Principles and Practices (ed. Fleming D.O. , & Hunt D.L. ), 3rd edn, pp. 221–241. Washington, DC, USA: ASM Press.

Frommer W. , Ager B. , Archer L. , Brunius G. , Collins C.H. , Donikian R. , Frontali C. , Hamp S. , Houwink E.H. , Kuenzi M.T. , Kramer P. , Lagast H. , Lund S. , Mahler J.L. , Normand-Plessier F. , Sargeant K. , Tuijnenburg Muijs G. , Vranch S.P. , & Werner R.G. (1993). Safe biotechnology recommendations for safe work with animal and human cell cultures concerning potential human pathogens. Applied Microbiology and Biotechnology 39, 141–147.

Anon. (1980). Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure of 28 April 1977, as amended on 26 September 1980. Geneva, Switzerland: World Intellectual Property Organisation. Website http://www.cnpat.com/worldlaw/treaty/budapest_en.htm.

Russell W.M.S. , & Burch R.L. (1959). The Principles of Humane Experimental Technique, 238 pp. London, UK: Methuen.

van der Valk J. , Mellor D. , Brands R. , Fischer R. , Gruber F. , Gstraunthaler G. , Hellebrekers L. , Hyllner J. , Jonker F.H. , Prieto P. , Thalen M. , & Baumans V. (2004). The humane collection of fetal bovine serum and possibilities for serum-free cell and tissue culture. Toxicology in Vitro 18, 1–12.

Jochems C.E.A. , van der Valk J.B.F. , Stafleu F.R. , & Baumans V. (2002). The use of fetal bovine serum: ethical or scientific problem? ATLA 30, 219–227.

Anderson R. , O'Hare M. , Balls M. , Brady M. , Brahams D. , Burt A. , Chesné C. , Combes R.D. , Dennison A. , Garthoff B. , Hawskworth G. , Kalter E. , Lechat A. , Mayer D. , Rogiers V. , Sladowski D. , Southee J. , Trafford J. , van der Valk J. , & van Zeller A-M. (1998). The availability of human tissue for biomedical research. The report and recommendations of ECVAM workshop 32. ATLA 26, 763–777.

Anon. (2004). Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Official Journal of the European Union L102, 48–58.

Fleming D.O. , Richardson J.H. , & Tulis J.I. (1995). Laboratory Safety: Principles and Practice, 420 pp. ASM Press.

Caputo J. , Caron M. , Chen T.R. , Cour I. , Hay R. , Macy M. , Reid Y. , & Thompson A. (1992). ATCC Quality Control Methods for Cell Lines. 2nd edn, 132 pp. Manassas, VA, USA: American Type Culture Collection.

Caputo J.L. (1988). Biosafety procedures in cell culture. Journal of Tissue Culture Methods 11, 223–227.

U.S Government (1999). Biosafety in Microbiological and Biomedical Laboratories, Center for Disease Control. Website http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm.

Davis J.M. (2002). Basic Cell Culture: A Practical Approach, 2nd edn, 381 pp. Oxford, UK: University Press.

Doyle A. , & Griffiths J.B. , eds (1997). Mammalian Cell Culture: Essential Techniques, 174 pp. New York, NY, USA: John Wiley & Sons.

Doyle A. , Griffiths J.B. , & Newell D.G. , eds (1999). Cell and Tissue Culture: Laboratory Procedures, 700 pp. New York, NY, USA: John Wiley & Sons.

Lindl T. (2002). Zell- und Gewebekultur, 5th edn, 316 pp. Heidelberg & Berlin, Germany: Spektrum Akademischer Verlag.

Masters J.R.W. (2000). Animal Cell Culture: A Practical Approach, 3rd edn, 135 pp. Oxford, UK: Oxford University Press.

Spier R.E. (2000). Encyclopedia of Cell Technology, 1249 pp. New York, NY, USA: Wiley Biotechnology Encyclopedias.

Fedoroff S. (1967). Proposed usage of animal tissue culture terms. Experimental Cell Research 46, 642–648.

Hayflick L. (1990). In the interest of clearer communication. In Vitro Cellular and Developmental Biology 26, 1–6.

McKeehan W.L. , Barnes D. , Reid L. , Stanbridge E. , Murakami H , & Sato G. (1990). Frontiers in mammalian cell culture. In Vitro Cellular and Developmental Biology 26, 9–23.

Nardone R.M. (1987). Cell culture methodology from donor to cell lines. BioTechniques 5, 122–127.

Schaeffer W.I. (1984). Usage of vertebrate, invertebrate and plant cell, tissue and organ culture terminology. In Vitro 20, 19–24.

Schaeffer W.I. (1989). In the interest of clear communication. In Vitro Cellular and Developmental Biology 25, 389–390.

Strehl R. , Schumacher K. , deVries U. , & Minuth W.W. (2002). Proliferating cells versus differentiated cells in tissue engineering. Tissue Engineering 8, 37–42.

Vierck J.L. , & Dodson M.V. (2000). Interpretation of cell culture phenomena. Methods in Cell Science 22, 79–81.

Vierck J.L. , Byrne K. , Mir P.S. , & Dodson M.V. (2000). Ten commandments for preventing contamination of primary cell cultures. Methods in Cell Science 22, 33–41.

Bettger W.J. , & McKeehan W.L. (1986). Mechanisms of cellular nutrition. Physiological Reviews 66, 1–35.

Butler M. , & Jenkins H. (1989). Nutritional aspects of the growth of animal cells in culture. Journal of Biotechnology 12, 97–110.

Cartwright T. , & Shah G.P. (2002). Culture media. In Basic Cell Culture: A Practical Approach (ed. Davis J.M. ), 2nd edn, pp. 69–106. Oxford, UK: Oxford University Press.

Ham R.G. , & McKeehan W.L. (1979). Media and growth requirements. Methods in Enzymology 58, 44–93.

Morton H.J. (1979). A survey of commercially available tissue culture media. In Vitro 6, 89–108.

Barnes D. , & Sato G. (1980). Methods for growth of cultured cells in serum-free medium. Analytical Biochemistry 102, 255–270.

Barnes D. , & Sato G. (1980). Serum-free cell culture: a unifying approach. Cell 22, 649–655.

Barnes D. , McKeehan W.L. , & Sato G.H. (1987). Cellular endocrinology: integrated physiology in vitro. In Vitro Cellular and Developmental Biology 23, 659–662.

Bjare U. (1992). Serum-free cell culture. Pharmacology and Therapeutics 53, 355–374.

Bottenstein J. , Hayashi I. , Hutchings S. , Masui H. , Mather J. , McClure D.B. , Ohasa S. , Rizzino A. , Sato G. , Serrero G. , Wolfe R. , & Wu R. (1979). The growth of cells in serum-free hormone-supplemented media. Methods in Enzymology 58, 94–109.

Defrancesco L. (1998). Serum-free cell culture: from art to science in 25 years. The Scientist 12, 19–24.

Froud S.J. (1999). The development, benefits and disadvantages of serum-free media. Developments in Biological Standardization 99, 157–166.

Gstraunthaler G. (2003). Alternatives to the use of fetal bovine serum: serum-free cell culture. ALTEX 20, 275–281.

Jayme D.W. (1999). An animal origin perspective of common constituents of serum-free medium formulations. Developments in Biological Standardization 99, 181–187.

Jayme D.W. , Epstein D.A. , & Conrad D.R. (1988). Fetal bovine serum alternatives. Nature, London 334, 547–548.

Price P.J. , & Gregory E.A. (1982). Relationship between in vitro growth promotion and biophysical and biochemical properties of the serum supplement. In Vitro 18, 576–584.

Shailer C. , & Corrin K. (1999). Serum supply: policies and controls operating in New Zealand. Developments in Biological Standardization 99, 71–77.

Wessman S.J. , & Levings R.L. (1999). Benefits and risks due to animal serum used in cell culture production. Developments in Biological Standardization 99, 3–8.

Zimmermann A.M. , Vierck J.L. , O'Reilly B.A. , & Dodson M.V. (2000). Formulation of a defined medium to maintain cell health and viability in vitro. Methods in Cell Science 22, 43–49.

Coriel L.L. (1979). Preservation, storage, and shipment. Methods in Enzymology 58, 29–36.

Drexler H.G. , & Uphoff C.C. (2002). Mycoplasma contamination of cell cultures: incidence, sources, effects, detection, elimination, prevention. Cytotechnology 39, 75–90.

Drexler H.G. , Uphoff C.C. , Dirks W.G. , & MacLeod R.A.F. (2002). Mix-ups and mycoplasma: the enemies within. Leukemia Research 26, 329–333.

Freshney R.I. (2002). Cell line provenance. Cytotechnology 39, 55–67.

Hay R.J. (1988). The seed stock concept and quality control for cell lines. Analytical Biochemistry 171, 225–237.

Hay R.J. , Reid Y.A. , McClintock P.R. , Chen T.R. , & Macy M.L. (1996). Cell line banks and their role in cancer research. Journal of Cellular Biochemistry, Suppl. 24, 107–130.

MacLeod R.A.F. , & Drexler H.G. (2001). Cell banks detect false cell lines: journals must act too. Lancet Oncology 2, 467–468.

MacLeod R.A.F. , Dirks W.G. , Matsuo Y. , Kaufmann M. , Milch H. , & Drexler H.G. (1999). Widespread intra-species cross-contamination of human tumor cell lines arising at source. International Journal of Cancer 83, 555–563.

Markovic O. , & Markovic N. (1998). Cell cross-contamination in cell cultures: the silent and neglected danger. In Vitro Cellular and Developmental Biolology 34, 1–8.

Masters J.R.W. (2000). Human cancer cell lines: fact and fantasy. Nature Reviews Molecular Cell Biology 1, 233–236.

Masters J.R.W. , Twentyman P. , Arlett C. , Daley R. , Davis J. , Doyle A. , Dyer S. , Freshney I. , Galpine A. , Harrison M. , Hurst H. , Kelland L. , Stacey G. , Stratford I. , & Ward T.H. (2000). UKCCCR guidelines for the use of cell lines in cancer research. British Journal of Cancer 82, 1495–1509.

Masters J.R. (2001). Short tandem repeat profiling provides an international reference standard for human cell lines. Proceedings of the National Academy of Sciences, USA 98, 8012–8017.

Masters J.R. (2002). HeLa cells 50 years on: the good, the bad and the ugly. Nature Reviews Cancer 2, 315–319.

Masters J.R. (2002). False cell lines: the problem and a solution. Cytotechnology 39, 69–74.

Mazur P. (1984). Freezing of living cells: mechanisms and implications. American Journal of Physiology 247, C125–C142.

McGarrity G.J. (1979). Detection of contamination. Methods in Enzymology 58, 18–29.

McGarrity G.J. (1982). Detection of mycoplasmal infection of cell cultures. Advances in Cell Culture 2, 99–131.

Nelson-Rees W.A. , Daniels D.W. , & Flandermeyer R.R. (1981). Cross-contamination of cells in culture. Science, New York 212, 446–452.

O'Brien S.J. (2001). Cell culture forensics. Proceedings of the National Academy of Sciences, USA 98, 7656–7658.

Peterson W.D. Jr. , Simpson W.F. , & Hukku B. (1979). Cell culture characterization: monitoring for cell identification. Methods in Enzymology 58, 164–178.

Stacey G.N. , Bolton B.J. , & Doyle A. (1992). DNA fingerprinting transforms the art of cell authentication. Nature, London 357, 261–262.

Stacey G.N. , Masters J.R.W. , Hay R.J. , Drexler H.G. , Macleod R.A.F. , & Freshney R.I. (2000). Cell contamination leads to inaccurate data: we must take action now. Nature, London 403, 356.

Barkley W.E. (1979). Safety considerations in the cell culture laboratory. Methods in Enzymology 58, 36–43.

Dormont D. (1999). Transmissible spongiform encephalopathy agents and animal sera. Developments in Biological Standardization 99, 25–34.

Eliot M. (1999). Risks of virus transmission associated with animal sera or substitutes and methods of control. Developments in Biological Standardization 99, 9–16.

Galbraith D.N. (2002). Transmissible spongiform encephalopathies and tissue cell culture. Cytotechnology 39, 117–124.

Merten O-W. (1999). Safety issues of animal products used in serum-free media. Developments in Biological Standardization 99, 167–180.

Merten O-W. (2002). Virus contaminations of cell cultures: a biotechnological view. Cytotechnology 39, 91–116.

Petricciani J.C. (1998). An overview of viral and viral-like agents in cell culture systems. Cytotechnology 28, 49–52.

Stacey G. , Doyle A. , & Hambleton P. (1998). Safety in Cell and Tissue Culture, 248 pp. Dordrecht, The Netherlands: Kluwer Academic Publishers.

Anon. (1997). Information Resources for Adjuvants and Antibody Production: Comparisons and Alternative Technologies. Animal Welfare Information Centre Resource Series No. 3. Beltsville, MD, USA: Animal Welfare Information Centre, National Agricultural Library, US Department of Agriculture. Website http://www.nal.usda.gov/awic/pubs/antibody.

Anon. (1994). Production and Quality Control of Monoclonal Antibodies. Guideline 3AB4a, revised and adopted December 1994. 25 pp. London, UK: Committee for Medicinal Products for Human Use (CHMP), European Medicines Evaluation Agency. (See also Concept on the Need to Revise the Guideline on Production and Quality Control of Monoclonal Antibodies (3AB4a December 1994), Reference CHMP/BWP/6404, 3 pp. London, UK: CHMP, EMEA.)

Amyx H. (1987). Control of animal pain and distress in antibody production and infectious disease studies. Journal of the American Veterinary Association 191, 1287–1289.¹

Anon. (2001). Guidelines on Monoclonal Antibody Production. 19 pp. Canberra, Australia: National Health & Medical Research Council. Website http://www.health.gov.au/nhmrc/research/awc/monosyn.htm¹

Clark A. , Befus D. , O'Hashi P. , Hart F. , Schunk M. , Fletch A. , & Griffin G. (2002). Canadian Council on Animal Care Guidelines: Antibody Production, 43 pp. Ottawa, Ontario, Canada: CCAC. Website http://www.ccac.ca¹

DeTolla L. , & Smith J. (2000). Guidance Document for IACUC Evaluation of Monoclonal Antibody Production Protocols, 8 pp. Jenkintown, PA, USA: Alternatives Research and Development Foundation. Website http://altweb.jhsph.edu/topics/mabs/ardf/guidance.htm¹

Grumstrup-Scott J. , & Greenhouse D.D. (1988). NIH intramural recommendations for the research use of complete Freund's adjuvant. ILAR News 30, 9.¹

Hanly W.C. , Taylor Bennett B. , & Artwohl J.E. (1997). Overview of Adjuvants, 5 pp. Beltsville, MD, USA: Animal Welfare Information Centre, National Agricultural Library, US Department of Agriculture. Website http://www.nal.usda.gov/awic/pubs/antibody/overview.htm¹

Hendriksen C.F.M. (1998). A call for a European prohibition of monoclonal antibody production by the ascites procedure in laboratory animals. ATLA 26, 523–540.¹

Jackson L.R. , & Fox J.G. (1995). Institutional policies and guidelines on adjuvants and antibody production. ILAR Journal 37, 141–152.¹

Jackson L.R. , Trudel L.J. , Fox J.G. , & Lipman N.S. (1996). Evaluation of hollow fiber bioreactors as an alternative to murine ascites production for small scale monoclonal antibody production. Journal of Immunological Methods 189, 217–231.¹

Jennings V.M. (1995). Review of selected adjuvants used in antibody production. ILAR Journal 37, 119–125.¹

Leenars M. , Claassen E. , & Hendriksen C.F.M. (1996). Considering the side-effects of adjuvant products in immunization procedures. Lab Animal 25, 40–43.¹

Marx U. , Embleton M.J. , Fischer R. , Gruber F.P. , Hansson U. , Heuer J. , de Leeuw W.A. , Logtenberg T. , Merz W. , Portetelle D. , Romette J-L. , & Straughan D.W. (1997). Monoclonal antibody production. The report and recommendations of ECVAM workshop 23. ATLA 25, 121–135.¹

McGill M.W. , & Rowan A.N. (1989). Refinement of monoclonal antibody production and animal well-being. ILAR News 31, 7–11.

Schulhof J. , ed. (1999). Small-Scale Monoclonal Antibody Production Lab Animal Autumn 1989, 1–35.¹

Workman P. , Twentyman P. , Balkwill F. , Balmain A. , Chaplin D. , Double J. , Embleton J. , Newell D. , Raymond R. , Stables J. , Stephens T , & Wallace J. (1997). UKCCCR Guidelines for the Welfare of Animals in Experimental Neoplasia, 2nd edn, 29 pp. London, UK: UKCCCR.¹

Anon. (1997). Proceedings for Alternatives and Monoclonal Antibody Production, a workshop of The John Hopkins Centre and The Office for Protection from research Riaks, National Institutes for Health, 3 pp. Baltimore, MD, USA: CAAT. Website http://altweb.jhsph.edu/meetings/mab/proceedings.htm¹

Anon. (2002). A Code of Practice for the Production of Human-derived Therapeutic Products. Originally produced by the Medical Devices Agency, 34 pp. London, UK: Medicines and Healthcare products Regulatory Agency.

DSMZ – German Collection of Microorganisms and Cell Cultures:

European Collection of Cell Cultures (ECACC): http://www.ecacc.org.uk

American Type Culture Collection (ATCC): http://www.atcc.org

CABRI – Common Access to Biotechnological Resources and Information: http://www.cabri.org

Italian Cell Line Collection: http://www.iclc.it

UK Stem Cell Bank: http://www.ukstemcellbank.org.uk

http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/fs/en (UK Department of Health policy and guidance on prions, Creutzfeld-Jakob Disease [CJD] Hepatitis A, B and C, and HIV)

http://www.osha-slc.gov/SLTC/laboratories/ (US guidelines on occupational health and laboratory safety)

http://biosafety.ihe.be (Belgian Biosafety Server)

http://www.cdc.gov/od/ohs/safety/labsafetyhm.htm (Centre for Disease Control and Prevention [CDC] laboratory safety primer)

http://www.phppo.cdc.gov.nltn/pdf/lrawwh.pdf (CDC risk assessment resource)

http://www.hse.gov.uk/pubns/indg163.pdf (UK Health & Safety Executive resource for general risk assessment)

http://www.who.org (World Health Organisation)

http://www.osha-slc.gov/SLTC/laboratories/ (US Occupational Safety and Health Administration resource for laboratory safety)

http://www.bocgases.ie/saftey/othersaftey/pdf/cryogenics.pdf (guidance on the safe use of liquid nitrogen and other liquid gases)