Developments in Biologicals / Vaccine Cell Substrates 2004

Introduction; Introduction to Vaccine Cell Substrates 2004: Sheets, R.L.; Potential Oncogenicity of Cellular DNA; Cell Substrates: Where do we Stand after 50 Years of Discussion?: Petricciani, J.; The Uptake and Fate of Exogenous Cellular DNA in Mammalian Cells: Strain, A.J.; Lessons Learned from Gene Therapy Concerning and the Use of Integrating Vectors and the Possible Risk of Insertional Oncogenesis: Cichutek, K.; Adaptation of the WHO Guideline for Residual DNA in Parenteral Vaccines Produced on Continuous Cell Lines to a Limit for Oral Vaccines: Lebron, J.A.; Troilo, P.J.; Pacchione, S. et al.; Biological Activity of Residual Cell-Substrate DNA: Peden, K.; Sheng, L.; Pal, A.; Lewis, A.; Potential Oncogenicity of Viruses Latent in Cells; Molecular Methods for Virus Discovery: Jarrett, R.F.; Johnson, D.; Wilson, K.; Gallagher, A.; Significance of Retrovirus Contaminants of Cell Substrates (Abstract): Coffin, J.M.; Practical Assay Issues with the PERT/PBRT Assay: A Highly Sensitive Reverse Transcriptase Assay: Chang, A.; Dusing, S.; Antibodies to SV40 in Sera from Humans and Macaques: Minor, P.; Pipkin, P.A.; Polio Vaccines, SV40 and Human Tumours, an Update on False Positive and False Negative Results: Elmishad, A.G.; Bocchetta, M.; Pass, H.I.; Carbone, M.; Routine Adventitious Agent Tests - Can in Vivo Methods be Replaced?; Adventitious Agent Test Methods: Sheets, R.L.; Scope and Practicality of in vivo Testing for Adventitious Agents: Whiteman, M.D.; Detection of Adventitious Viruses in Biologicals - A Rare Occurrence: Nims, R.W.; Approaches to the Release of a Master Cell Bank of PER.C6 Cells; A Novel Cell Substrate for the Manufacture of Human Vaccines: Lewis, J.A.; Brown, E.L.; Duncan, P.A.; Newer Molecular Approaches to Detect Known Viruses and Previously Unrecognized Viruses in Cell Substrates: Wright, P.F.; A Cell-Based Assay for Mouse Prions (Abstract): Weissmann, Ch.; Level of Assurance Provided by Guidelines, Especially ICH Q5A and Q5D; Basis for Sample Size in International Conference on Harmonization Guidances: Lubiniecki, A.; The Impact of Technology on Assurance (Abstract): Moore, W.A.; Statistical Bases for Defining Level of Assurance: Schofield, T.; Experience with Novel Cell Lines; Comprehensive Characterization of the 293-ORF6 Cell Line: Butman, B.T.; Lizonova, A. et al.; Insect Cells as a New Substrate for Vaccine Production: Dalemans, W.; Safety Assessment of Madin Darby Canine Kidney Cells as Vaccine Substrate: Medema, J.K. et al.; Tumorigenicity Assessments of PER.C6[registered] Cells and of an Ad5-Vectored HIV-1 Vaccine Produced on this Continuous Cell Line: Ledwith, B.J.; Lanning, C.L.; Gumprecht, L.A. et al; Bovine (and Porcine) Viruses; Bovine Serum - Regulatory Issues: Robertson, J.S.; Vaccine Cell Substrates: Bovine and Porcine Virus Considerations: Wessman, S.J.; Assays for Bovine Viruses (Abstract): Wisher, M.; Animal-Free Culture Process for Manufacture of Viral Vaccines: Process Validation and Regulatory Perspectives: Pierard, I.; Mareschal, J.-C. et al.; Bovine Spongiform Encephalopathy; Susceptibility of Common Laboratory Fibroblasts to TSE Infection (Abstract): Priola, S.A.; Diagnostics for TSE Agents: Raeber, A.J.; Oesch, B.; Production Cell Substrates and vCJD: Minor, P.D.; Cooper, J.; TSE Risk Assessment for Starting Materials Used During, or in the Manufacture of Vaccines for Human Use - A Consultant's View of the Commercial Approach: Bradley, R.; Bovine Spongiform Encephalopathy (BSE) in the United States: an Overview and Critique of the Response with Suggestions for Additional Actions (Abstract): Detwiler, L.A..