Vaccine Design pp 187-196 | Cite as

From Scientific Discovery to Clinical Trial: Overcoming the Regulatory Hurdles — A Guide for Academic Researchers

  • Jillian K. Bennet
Part of the NATO ASI Series book series (NSSA, volume 293)


Vaccines have a distinguished history originating from the demonstration by Jenner in 1796 that cowpox could protect against the development of smallpox. Historically, the objective of vaccination was to provide effective immunity to the target disease, and with the introduction earlier this century of widespread immunisation for diseases such as diphtheria, tetanus, polio, smallpox and pertussis, the occurrence of these diseases has been significantly reduced if not eliminated. However, the acceptance of immunisation programs in the community could have been jeopardised by the rare events which occurred as a result of poor vaccine manufacture.


Good Laboratory Practice Therapeutic Good Administration Regulatory Hurdle Master Cell Bank Somatic Cell Therapy 
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  1. James, R.W., 1994, Toxicity Testing Strategies for Biotechnology-Derived and High Technology Products, BIRA Journal, 12: 10.Google Scholar
  2. OECD, 1992, The OECD Principles of Good Laboratory Practice, Environment Monograph No.45. Organisation For Economic Co-operation and Development, OCDE/GD(92)32, Paris.Google Scholar

Copyright information

© Springer Science+Business Media New York 1997

Authors and Affiliations

  • Jillian K. Bennet
    • 1
  1. 1.Research & Development DivisionCSL LtdAustralia

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