Viral Clearance in Biopharmaceutical Manufacture
Brown F, Lubiniecki AS (eds.): Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products. Dev Biol Stand, vol 88, Karger, Basel (1996)
Charm SE et al.: High-Temperature Short-Time Heat Inactivation of HIV and Other Viruses in Human Blood Plasma. Vox Sanguinis (1992) 62: 12-20
Werz W, Hoffmann H, Haberer K, Walter JK: Strategies to avoid virus transmissions by biopharmaceutic products. Arch Virol (1997) [ Suppl ] 13: 245-256
Walter JK, Nothelfer F, Werz W: Virus Removal and Inactivation: A Decade of Validation Studies - Critical Evaluation of the Data Set. In: Validation of Biopharmaceutical Manufacturing Processes, ACS Symposium Series 698, eds. Kelley BD, Ramelmeier RA, American Chemical Society, Washington, DC (1998): 114-124
Walter JK, Nothelfer F, Werz W: Validation of Viral Safety for Pharmaceutical Proteins. In: Bioseparation and Bioprocessing, Vol 1, Subramanian G, Wiley-VCH Weinheim (1998): 465-496
Downstream Processing of Biopharmaceuticals
Berthold W, Walter JK: Protein Purification: Aspects of Processes for Pharmaceutical Products. Biologicals (1994) 22, 135-150
Regulatory Guidelines:
ICH Q5A Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, 1997 Published as: CPMP/ICH/295/95 and US Federal Register Vol 63, No 185 (1998): 51074-51084
Committee for Proprietary Medicinal Products: Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses. CPMP/BWP/268/95 (1996)
Committee for Proprietary Medicinal Products: Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents Via Medicinal Products. CPMP/BWP/8777/96 (1997)
Center for Biologics Evaluation and Research: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. CBER (1997)
Committee for Proprietary Medicinal Products: Note for Guidance on Plasma Derived Medicinal Products. CPMP/BWP/269/95 (1996)
Federal Health Agency and Paul Ehrlich Institute: Announcement on the Marketing of Medicinal Products Ò Requirements of Validation Studies for Demonstrating the Virus Safety of Medicinal Products derived from Human Blood or Plasma. Federal Gazette No. 84 (1994)
United States Patent numbers for Charm Patents on Microwave Viral Inactivation:
U.S. Patent No. 5,539,673 - Non-invasive Infrared Temperature Sensor, System and Method - July 23, 1996, Charm, Landau, Zarrineghbal, Golden
U.S. Patent No. 5,389,335 - High Temperature, Short Time Microwave Heating System and Method of Heating Heat-Sensitive Material - February 14, 1995, Charm, Landau, Zarrineghbal, Golden
U.S. Patent No. 4,975,246 - High Temperature, Short Time Heating System and Method of Heating Heat-Sensitive Material - December 4, 1990, Stanley E. Charm
U.S. Patent No. 4,839,142 - High Temperature, Short Time Heating System and Method of Sterilizing or Pasteurizing Heat Sensitive Biological Fluids - June 13, 1989, Stanley E. Charm
©1999 Charm Bioengineering, Inc.