Abstract
Rapid progress during the last decade in the research and development of recombinant DNA biologicals opens the way to numerous applications. In parallel with new product development arises the need for adequate regulation. Authorities rapidly responded by issuing “guidelines”, “points to consider”, requirements and directives for this class of biologicals in general and for vaccines in particular (Ref. 1 to 7).
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References
‘Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology’, Office of Biologics Research and Review, Center for Drugs and Biologics, U.S.A., Draft (April 10, 1988).
‘Standardization and Control of the Biological Medicinal Products of Recombinant DNA and Hybridoma Technologies and of Products Derived from Aneuploid cells’, The National Institute for Biological V7 Standards and Control, Holly Hill, Hampstead, London NW3 6RB.
‘Guidelines on the Production and Quality Control of Medicinal Products derived by Recombinant DNA Technology’, Commission of the European Communities - Notes to Applicants for Marketing Authorizations, Committee for Proprietary Medicinal Products Ad Hoc Working Party on Biotechnology/ Pharmacy, December 1987.
‘Quality Assurance in the Manufacture of Products derived from Biotechnology’, Conference organized by the EOQC Pharma Section, Frankfurt, FRG, December 1–2, 1988.
‘Issues and Concepts regarding Compendial Requirements for Biotechnology Products’, PMA (USA), QC Section, Biotechnology Committee, Pharmacopeial Forum, July-August 1989, pp. 5402–5405.
European Pharmacopoeia Commission 1988a: ‘Draft Monograph on Biologicals produced by Recombinant DNA Technology’ (PA/PH/Exp.6/T(87)30, 2nd Rev.).
‘Requirements for Hepatitis-B Vaccines Made by Recombinant DNA Techniques in Yeast’, World Health Organization, Technical Report Series, no. 760 (1987).
Peetermans, J. H. (1987) ‘Specifications and Quality Control of a Yeast-Derived Hepatitis-B Vaccine’, Postgraduate Medical Journal 63 (Suppl. 2) 97–100.
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© 1990 Springer Science+Business Media Dordrecht
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Peetermans, J.H. (1990). Quality Control of Vaccines. In: Crommelin, D.J.A., Schellekens, H. (eds) From Clone to Clinic. Developments in Biotherapy, vol 1. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-3780-5_4
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DOI: https://doi.org/10.1007/978-94-011-3780-5_4
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