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New approaches to the development of viral vaccines: Scientific and regulatory aspects
Author(s) -
Robertson James S.
Publication year - 1988
Publication title -
journal of chemical technology and biotechnology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.64
H-Index - 117
eISSN - 1097-4660
pISSN - 0268-2575
DOI - 10.1002/jctb.280430409
Subject(s) - control (management) , risk analysis (engineering) , component (thermodynamics) , information exchange , computer science , engineering ethics , management science , engineering , business , artificial intelligence , telecommunications , physics , thermodynamics
The revolution in biotechnology in the 1980s raises the possibility of producing vaccines which were hitherto difficult or impossible to produce by classical techniques. This revolution must be met by parallel considerations of appropriate evaluation and control procedures to ensure the safety and efficacy of such new vaccines. A significant problem of these new approaches is the difficulty in identifying a suitable subunit component able to induce a satisfactory protective immune response in the host. In addition vaccines produced in unusual cell substrates may contain contaminants not previously encountered by man. These and other problems are being met by the application of many of the control measures found useful in the past, by evaluation of all manufacturing processes, by the formulation of guidelines by international groups of experts, and by free international exchange of information on new problems of control as they arise.