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Home > Medicine & Health Science textbooks > Medical specialties, branches of medicine > Pathology > Medical microbiology and virology > PDA/EMEA European Virus Safety Forum: Langen, September-October 2003: Proceedings(118 Developments in Biologicals)
PDA/EMEA European Virus Safety Forum: Langen, September-October 2003: Proceedings(118 Developments in Biologicals)

PDA/EMEA European Virus Safety Forum: Langen, September-October 2003: Proceedings(118 Developments in Biologicals)


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About the Book

Viral safety is a key issue for biological and biotechnological med icinal products. This first joint PDA/EMEA European Virus Safety Fo rum brought together an international panel of speakers from the in dustry, regulatory authorities and research to present and discuss the most up-to-date scientific knowledge and regulatory aspects in the areas of virus safety of recombinant proteins, monoclonal antib odies, plasma-derived medicinal products and advanced technology me dicinal products. The conference provided the opportunity to discuss new approaches i n viral safety such as generic or matrix validation of virus remova l and novel virus inactivation/removal technologies, and to clarify their benefits and applicability for specific product categories o r technologies. This volume will further the discussion on virus sa fety, contribute to the development of new regulatory guidance and support harmonisation of the regulations in this field.

Table of Contents:
Regulatory Requirements European Regulatory Guidance on Virus Safety of Recombinant Protein s, Monoclonal Antibodies and Plasma-Derived Medicinal Products: Cel is, P.; Silvester, G. Viral Safety Evaluation of Plasma-Derived Therapeutic Products: Far shid, M. Current and Future Approaches to Ensure the Viral Safety of Biophar maceuticals: Brorson, K.; Norling, L.; Hamilton, E.; Lute, S.; Lee, K.; Curtis, S.; Xu, Y. An Industry Perspective on Plasma-Derived Products: von Hoegen, I. Industry Perspective for Biotech Products: Moritz, A. Testing Source Material Developing New Infectivity Assays: Galbraith, D.N. Qualification of Virus/Cell Systems for their Intended Use: Groner, A. West Nile Virus NAT Testing: Saldanha, J.; Cameron, C. Variants of B19: Brown, K.E. Virus Validation, Virus Assay and Standardisation Quantitative NAT for Pathogen Inactivation Verification: McKenney, K.; Gillmeister, L.; Marlowe, K.; Armistead, D.; Burgess, W.; Droha n, W. Use of Bacteriophages as Surrogates for Mammalian Viruses: McAliste r, M.; Aranha, H.; Larson, R. Virus Validation, Model Viruses West Nile Virus: Recent Experience with the Model Virus Approach: K reil, T.R. Cell Culture-Based Assay of Parvovirus B19 and the Relevance of Ani mal Model Viruses: Blumel, J. Methods for Validation of Hepatitis B Virus Inactivation: Gerlich, W.H.; Glebe, D. Virus Inactivation/Removal Technologies: Application and Validation Robustness Studies on Virus Inactivation: Definition of Parameters and their Generic Use: Dichtelmuller, H. PDA Virus Filter Task Force Update: Sofer, G. Gamma Irradiation of Intravenous Immunoglobulin: Drohan, W.N.; Miek ka, S.I.; Griko, Y.V.; Forng, R.-Y.; Stafford, R.E.; Hill, C.R.; Ma nn, D.M.; Burgess, W.H. UV-C Irradiation of Human Albumin Solution on Manufacturing Scale: MacLeod, A.J. Virus Safety Aspects of Advanced Technology Medicinal Products Virological Issues in the Use of Cell Therapies: Minor, P.D. Animal Virus Contaminants of Biotechnology Products: Onions, D. Transgenic Animals for the Production of Biological Medicines: Mino r, P.D.


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Product Details
  • ISBN-13: 9783805578738
  • Publisher: S Karger Ag
  • Publisher Imprint: S Karger AG
  • Language: English
  • Series Title: 118 Developments in Biologicals
  • Weight: 380 gr
  • ISBN-10: 3805578733
  • Publisher Date: 01 Dec 2004
  • Binding: Paperback
  • No of Pages: 180
  • Sub Title: Langen, September-October 2003: Proceedings


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