Viral contamination in biologic manufacture and implications for emerging therapies
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David W. Roush | S. Springs | A. Sinskey | P. Barone | D. Roush | T. Kreil | R. Kiss | L. Mallet | I. Hussein | Dayue Chen | J. Müllberg | J. Wolfrum | Christian Menzel | S. Monpoeho | R. Schicho | N. Roth | A. Brussel | L. Gérentes | F. J. Keumurian | J. C. Leung | Marie Murphy | M. Wiebe | Richard Snyder | M. Moody | H. Dehghani | M. Plavsic | James Bouressa | Ming Chong | James Gilbert | D. Gold | R. Labatut | Yuling Li | Michel Ruffing | D. Stark | Chun Zhang | M. Moody | I. Hussein | J. Leung | Marie A. Murphy | R. Snyder | Daniel Stark | Dayue Chen | René Labatut | Mark Moody | Islam T. M. Hussein | M. Chong | Jürgen Müllberg
[1] Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin , 2021, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.
[2] M. Eloit,et al. Use of a new RNA next generation sequencing approach for the specific detection of virus infection in cells. , 2019, Biologicals : journal of the International Association of Biological Standardization.
[3] Michael DiCuccio,et al. Erratum: Bringing up baby , 2018, Nature Biotechnology.
[4] FDA approves hereditary blindness gene therapy , 2018, Nature Biotechnology.
[5] E. Waltz. With a free pass, CRISPR-edited plants reach market in record time , 2018, Nature Biotechnology.
[6] Asher Mullard,et al. Second anticancer CAR T therapy receives FDA approval , 2017, Nature Reviews Drug Discovery.
[7] Asher Mullard,et al. BTK inhibitors get a boost , 2017, Nature Reviews Drug Discovery.
[8] R. L. Charlebois,et al. A Multicenter Study To Evaluate the Performance of High-Throughput Sequencing for Virus Detection , 2017, mSphere.
[9] Shakir Ali,et al. Microbial and viral contamination of animal and stem cell cultures: common contaminants, detection and elimination , 2017 .
[10] M. Aucoin,et al. Evaluating ultraviolet sensitivity of adventitious agents in biopharmaceutical manufacturing , 2017, Journal of Industrial Microbiology & Biotechnology.
[11] Arifa S Khan,et al. Advanced Virus Detection Technologies Interest Group (AVDTIG): Efforts on High Throughput Sequencing (HTS) for Virus Detection , 2016, PDA Journal of Pharmaceutical Science and Technology.
[12] K. Bergmann,et al. Vesivirus 2117: Cell line infectivity range and effectiveness of amplification of a potential adventitious agent in cell culture used for biological production. , 2016, Biologicals : journal of the International Association of Biological Standardization.
[13] M. Takagi,et al. Design of serum-free medium for suspension culture of CHO cells on the basis of general commercial media , 2015, Cytotechnology.
[14] Hazel Aranha,et al. Viral clearance for biopharmaceutical downstream processes , 2015 .
[15] Gary Walsh,et al. Biopharmaceutical benchmarks 2014 , 2014, Nature Biotechnology.
[16] G. Ye,et al. Herpes simplex virus clearance during purification of a recombinant adeno-associated virus serotype 1 vector. , 2014, Human gene therapy. Clinical development.
[17] P. Duncan,et al. Systematic evaluation of in vitro and in vivo adventitious virus assays for the detection of viral contamination of cell banks and biological products. , 2014, Vaccine.
[18] K. Brorson,et al. Meeting Report: 2013 PDA Virus & TSE Safety Forum , 2014, PDA Journal of Pharmaceutical Science and Technology.
[19] T. Wirth,et al. History of gene therapy. , 2013, Gene.
[20] Kate Zhang,et al. Identification and quantitation of vesivirus 2117 particles in bioreactor fluids from infected Chinese hamster ovary cell cultures , 2013, Biotechnology and bioengineering.
[21] Dayue Chen,et al. Effectiveness of mouse minute virus inactivation by high temperature short time treatment technology: a statistical assessment. , 2011, Biologicals : journal of the International Association of Biological Standardization.
[22] F. Khan,et al. Mouse Minute Virus (MMV) Contamination—A Case Study: Detection, Root Cause Determination, and Corrective Actions , 2011, PDA Journal of Pharmaceutical Science and Technology.
[23] R. Kiss. Practicing Safe Cell Culture: Applied Process Designs for Minimizing Virus Contamination Risk , 2011, PDA Journal of Pharmaceutical Science and Technology.
[24] P. Krause,et al. Molecular and infectivity studies of porcine circovirus in vaccines. , 2011, Vaccine.
[25] Y. Qiu,et al. Caliciviridae and Vesivirus 2117 , 2011 .
[26] N. Bannert,et al. Analysis of porcine circovirus type 1 detected in Rotarix vaccine. , 2011, Vaccine.
[27] R. Nims,et al. Gamma-irradiation of serum for the inactivation of adventitious contaminants. , 2010, PDA journal of pharmaceutical science and technology.
[28] Mike Rubino. Experiences with HEK293: A Human Cell Line. , 2010, PDA journal of pharmaceutical science and technology.
[29] Crystal Jaing,et al. Viral Nucleic Acids in Live-Attenuated Vaccines: Detection of Minority Variants and an Adventitious Virus , 2010, Journal of Virology.
[30] Malorye Allison. As Genzyme flounders, competitors and activist investors swoop in , 2010, Nature Biotechnology.
[31] Victor Bethencourt. Virus stalls Genzyme plant , 2009, Nature Biotechnology.
[32] Prince Bhebe,et al. Susceptibility of mouse minute virus to inactivation by heat in two cell culture media types , 2009, Biotechnology progress.
[33] Thomas R Kreil,et al. Emerging trends in plasma‐free manufacturing of recombinant protein therapeutics expressed in mammalian cells , 2009, Biotechnology journal.
[34] T. Burnouf. Modern Plasma Fractionation , 2007, Transfusion Medicine Reviews.
[35] Steven Kozlowski,et al. Current and future issues in the manufacturing and development of monoclonal antibodies. , 2006, Advanced drug delivery reviews.
[36] J. P. Davis,et al. Second Human Case of Cache Valley Virus Disease , 2006, Emerging infectious diseases.
[37] Kurt Brorson,et al. The clearance of viruses and transmissible spongiform encephalopathy agents from biologicals. , 2005, Current opinion in biotechnology.
[38] Donna A. Almario,et al. Immunization Safety Review: SV40 Contamination of Polio Vaccine and Cancer , 2003 .
[39] M. Büttner,et al. Identification of a calicivirus isolate of unknown origin. , 2003, The Journal of general virology.
[40] O. Merten. Virus contaminations of cell cultures – A biotechnological view , 2002, Cytotechnology.
[41] C. Bennett,et al. Legal, Financial, and Public Health Consequences of HIV Contamination of Blood and Blood Products in the 1980s and 1990s , 2002, Annals of Internal Medicine.
[42] A. Ault. US FDA again stops urokinase sales , 1999, The Lancet.
[43] D. Sexton,et al. Life-threatening Cache Valley virus infection. , 1997, The New England journal of medicine.
[44] Louise Poissant. Part I , 1996, Leonardo.
[45] D. Besselsen,et al. Molecular characterization of newly recognized rodent parvoviruses. , 1996, The Journal of general virology.
[46] D. Swinbanks,et al. Health ministry accepts liability in Japanese HIV-infected blood row , 1996, Nature.
[47] D. Butler. Petition prompts backlash against scientists , 1994, Nature.
[48] P. Mellor,et al. Contamination of genetically engineered CHO-cells by epizootic haemorrhagic disease virus (EHDV). , 1993, Biologicals : journal of the International Association of Biological Standardization.
[49] F. Rosendaal,et al. Hemophilia treatment in historical perspective: a review of medical and social developments , 1991, Annals of Hematology.
[50] Mary K. Joscelyn,et al. Review and comment , 1977 .
[51] M. Eaton,et al. JAUNDICE IN ARMY PERSONNEL IN THE WESTERN REGION OF THE UNITED STATES AND ITS RELATION TO VACCINATION AGAINST YELLOW FEVERPART I , 1944 .
[52] T. Walter. A UNITED FRONT , 1935 .
[53] Achilleas Zapranis,et al. A Statistical Assessment , 2016 .
[54] Karen Godfrey-Edwards. A united front. , 2013, Midwives.
[55] Chris Mason,et al. Peak serum: implications of serum supply for cell therapy manufacturing. , 2012, Regenerative medicine.
[56] D. Onions,et al. Detection of Cache Valley Virus in Biologics Manufactured in CHO Cells , 2008 .
[57] R. Nims. Detection of adventitious viruses in biologicals--a rare occurrence. , 2006, Developments in biologicals.
[58] Nims Rw. Detection of adventitious viruses in biologicals--a rare occurrence. , 2006 .
[59] S. Lute,et al. Current and future approaches to ensure the viral safety of biopharmaceuticals. , 2004, Developments in biologicals.
[60] Donna A. Almario,et al. Immunization Safety Review , 2002 .
[61] Gary Walsh,et al. Biopharmaceutical benchmarks , 2000, Nature Biotechnology.
[62] J. Vennari,et al. Development and Qualification of a Novel Virus Removal Filter for Cell Culture Applications , 2000, Biotechnology progress.
[63] F. Brown,et al. WHO requirements for the use of animal cells as in vitro substrates for the production of biologicals (Requirements for biological substances N°50) : Safety of Biological Products Prepared from Mammalian Cell Culture , 1998 .
[64] Garnick Rl. Raw materials as a source of contamination in large-scale cell culture. , 1998 .
[65] R L Garnick,et al. Experience with viral contamination in cell culture. , 1996, Developments in biological standardization.
[66] D. Burstyn. Contamination of genetically engineered Chinese hamster ovary cells. , 1996, Developments in biological standardization.
[67] H. Suomela. Inactivation of viruses in blood and plasma products. , 1993, Transfusion medicine reviews.
[68] N. Nathanson,et al. Human exposure to SV40: review and comment. , 1976, American journal of epidemiology.