Biomedical Engineering Reference
In-Depth Information
European Commission Enterprise Directorate General. 2001. Working party on con-
trol of medicines and inspections. EU Guide to Good Manufacturing Practice,
Volume 4, Annex 15, July 2001, Cleaning Validation.
European Commission. 1992. Eudralex Vol. 4, Annex 12: Use of ionising radiation in
the manufacture of medicinal products. Brussels, Belgium
European Commission. 1992. Eudralex Vol. 4, Annex 14: Manufacture of products
derived form human blood or human plasma. Brussels, Belgium.
European Commission. 1992. Eudralex Vol. 4, Annex 2: Manufacture of biological
medicinal products for human use. Brussels, Belgium.
European Commission. 2001. Eudralex Vol. 4, Annex 15: Qualification and validation.
Brussels, Belgium.
European Commission. 2005. Eudralex Vol. 4, EU Guidelines to Good Manufacturing
Practice, part II: Basic requirements for active substances used as starting mate-
rials. Brussels, Belgium.
European Commission. 2008. Eudralex Vol. 4, Annex 1: Manufacture of sterile medici-
nal products. Brussels, Belgium.
European Commission. 2008. Eudralex Vol. 4, EU Guidelines to Good Manufacturing
Practice, part I: Basic requirements for medicinal products. Brussels, Belgium.
European Directorate for the Quality of Medicines & Healthcare. 2009. European
Pharmacopeia , Vol. 6.5, 6th ed. Strasbourg, France: Council of Europe.
European Medicines Evaluation Agency (EMEA). 2005. Guideline on Plastic
Immediate Packaging Materials. CHMP/CVMP 205/04.
European Parliament and the Council of the European Union on Packaging and
Packaging Waste. 1994. European Parliament and Council Directive 94/62/
EC on Packaging and Packaging Waste.; http://www.eur-lex.europa.eu/
LexUriServ/LexUriServ.do?uri=CELEX:31994L0062 : EN:HTML.
Extractables and Leachables Subcommittee of the Bio-Process Systems Alliance. 2008.
Recommendations for extractables and leachables testing. BioProcess Int. 6(5):
S28-S39.
Fahrner, R.L., Iyver, H.V., and Blank, G.S. 1999. The optimal flow rate and column
length for maximum production rate of protein A chromatography. Bioprocess
Eng . 21: 287-292.
Fahrner, R.L., Knudsen, H.L., Basey, C.D., Galan, W., and Feuerhelm, D. 2001.
Industrial purification of pharmaceutical antibodies: Development, operation,
and validation of chromatography processes. Biotechnol. Genet. Eng. Rev. 18:
301-327.
Falch, F.A. and Heden, C.G. 1963. Disposable shaker flasks. Biotechnol. Bioeng . 5:
211-220.
Falkenberg, F.W. 1998. Production of monoclonal antibodies in the miniPerm bio-
reactor: Comparison with other hybridoma culture methods. Res. Immunol . 6:
560-570.
Farid, S.S., Washbrook, J., and Titchener-Hooker, N.J. 2005. Decision-support tool for
assessing biomanufacturing strategies under uncertainty: Stainless steel versus
disposable equipment for clinical trial material preparation. Biotechnol. Prog . 21
(2): 486-497.
Farid, S.S. 2007. Process economics of industrial monoclonal use systems, part 2.
BioProcess Int. (Suppl. 3): 51-56.
Search WWH ::




Custom Search