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Full Description
Viral safety is a key issue for biological and biotechnological medicinal products. This first joint PDA/EMEA European Virus Safety Forum brought together an international panel of speakers from the industry, 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 antibodies, plasma-derived medicinal products and advanced technology medicinal products. The conference provided the opportunity to discuss new approaches in viral safety such as generic or matrix validation of virus removal and novel virus inactivation/removal technologies, and to clarify their benefits and applicability for specific product categories or technologies. This volume will further the discussion on virus safety, contribute to the development of new regulatory guidance and support harmonisation of the regulations in this field.
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.
