-
1
-
-
0037087046
-
Emerging Infectious Agents: Do They Pose a Risk to the Safety of Transfused Blood and Blood Products?
-
Chamberland, M. E. Emerging Infectious Agents: Do They Pose a Risk to the Safety of Transfused Blood and Blood Products? Clin. Infect. Dis. 2002, 34, 797-805.
-
(2002)
Clin. Infect. Dis
, vol.34
, pp. 797-805
-
-
Chamberland, M.E.1
-
2
-
-
0036588697
-
Evolving Perspectives in Product Safety for Haemophilia
-
Farrugia, A. Evolving Perspectives in Product Safety for Haemophilia. Haemophilia. 2002, 8, 236-243.
-
(2002)
Haemophilia
, vol.8
, pp. 236-243
-
-
Farrugia, A.1
-
3
-
-
25844440975
-
The Clearance of Viruses and Transmissible Spongiform Encephalopathy Agents from Biologicals
-
Farshid, M.; Taffs, R. E.; Scott, D.; Asher D. M.; Brorson, K. The Clearance of Viruses and Transmissible Spongiform Encephalopathy Agents from Biologicals. Curr. Opin. Biotechnol. 2005, 16, 561-567.
-
(2005)
Curr. Opin. Biotechnol
, vol.16
, pp. 561-567
-
-
Farshid, M.1
Taffs, R.E.2
Scott, D.3
Asher, D.M.4
Brorson, K.5
-
4
-
-
0030334226
-
Experience with Viral Contamination in Cell Culture
-
Garnick, R. L. Experience with Viral Contamination in Cell Culture. Dev. Biol. Stand. 1996, 88, 49-56.
-
(1996)
Dev. Biol. Stand
, vol.88
, pp. 49-56
-
-
Garnick, R.L.1
-
5
-
-
0031615735
-
Materials as a Source of Contamination in Large-Scale Cell Culture
-
Garnick, R. L. Raw Materials as a Source of Contamination in Large-Scale Cell Culture. Dev. Biol. Stand. 1998, 93, 21-29.
-
(1998)
Dev. Biol. Stand
, vol.93
, pp. 21-29
-
-
Garnick, R.1
Raw, L.2
-
6
-
-
0015821572
-
Mammalian Cells in Culture Frequently Release Type C Viruses
-
Lieber, M. M.; Benveniste, R. E.; Livingston, D. M.; Todaro, G. J.; Mammalian Cells in Culture Frequently Release Type C Viruses. Science. 1973, 182(107), 56-59.
-
(1973)
Science
, vol.182
, Issue.107
, pp. 56-59
-
-
Lieber, M.M.1
Benveniste, R.E.2
Livingston, D.M.3
Todaro, G.J.4
-
7
-
-
57749112598
-
-
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). European Medicines Agency: 1995.
-
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). European Medicines Agency: 1995.
-
-
-
-
9
-
-
57749118958
-
-
Quality Guideline Q5A: Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin. International Conference on Harmonisation: 1997.
-
Quality Guideline Q5A: Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin. International Conference on Harmonisation: 1997.
-
-
-
-
10
-
-
57749086529
-
Considerations for Developing Biopharmaceuticals: FDA Perspective
-
Knablein, J, Ed, WILEY-VCH Verlag GmbH & Co, KGaA: Weinheim, Germany
-
Brorson, K.; Swann, P. G.; Brown, J.; Wilcox, B.; Shapiro, M.; Considerations for Developing Biopharmaceuticals: FDA Perspective. In Modern Biopharmaceuticals Design, Development and Optimization; Knablein, J., Ed.; WILEY-VCH Verlag GmbH & Co, KGaA: Weinheim, Germany, 2005; Vol. 4, pp 1637-1668.
-
(2005)
Modern Biopharmaceuticals Design, Development and Optimization
, vol.4
, pp. 1637-1668
-
-
Brorson, K.1
Swann, P.G.2
Brown, J.3
Wilcox, B.4
Shapiro, M.5
-
11
-
-
0035139317
-
Viral Clearance Strategies for Biopharmaceutical Safety. Part 1: General Considerations
-
Aranha, H.; Viral Clearance Strategies for Biopharmaceutical Safety. Part 1: General Considerations. Biopharm Intl. 2001, 14(2), 28-35.
-
(2001)
Biopharm Intl
, vol.14
, Issue.2
, pp. 28-35
-
-
Aranha, H.1
-
12
-
-
0035110750
-
Viral Clearance Strategies for Biopharmaceutical Safety. Part 2: Filtration for Viral Clearance
-
Aranha, H.; Viral Clearance Strategies for Biopharmaceutical Safety. Part 2: Filtration for Viral Clearance. Biopharm Intl. 2001, 14(2), 32-43.
-
(2001)
Biopharm Intl
, vol.14
, Issue.2
, pp. 32-43
-
-
Aranha, H.1
-
13
-
-
0030918447
-
Virus Retention by a Hydrophilic Triple-layer PVDF Microporous Membrane Filter
-
Aranha-Creado, H.; Oshima, K.; Jafari, S.; Howard, G. Jr.; Brandwein, H. Virus Retention by a Hydrophilic Triple-layer PVDF Microporous Membrane Filter. PDA J Pharm. Sci. Technol. 1997, 51, 119-124.
-
(1997)
PDA J Pharm. Sci. Technol
, vol.51
, pp. 119-124
-
-
Aranha-Creado, H.1
Oshima, K.2
Jafari, S.3
Howard Jr., G.4
Brandwein, H.5
-
14
-
-
0028095069
-
Nanofiltration, A New Specific Virus Elimination Method Applied to High-purity Factor IX and Factor XI Concentrates
-
Burnouf-Radosevich, M.; Appourchaux, P.; Huart, J. J.; Burnouf, T. Nanofiltration, A New Specific Virus Elimination Method Applied to High-purity Factor IX and Factor XI Concentrates. Vox Sang. 1994, 67, 132-138.
-
(1994)
Vox Sang
, vol.67
, pp. 132-138
-
-
Burnouf-Radosevich, M.1
Appourchaux, P.2
Huart, J.J.3
Burnouf, T.4
-
15
-
-
0027746166
-
Size Exclusion Removal of Model Mammalian Viruses Using a Unique Membrane System, Part II: Module Qualification and Process Simulation
-
DiLeo, A.J.; Vacante, D. A.; Deane, E. F. Size Exclusion Removal of Model Mammalian Viruses Using a Unique Membrane System, Part II: Module Qualification and Process Simulation. Biologicals. 1993, 21, 287-296.
-
(1993)
Biologicals
, vol.21
, pp. 287-296
-
-
DiLeo, A.J.1
Vacante, D.A.2
Deane, E.F.3
-
16
-
-
0027732635
-
Size Exclusion Removal of Model Mammalian Viruses Using a Unique Membrane System, Part I: Membrane Qualification
-
DiLeo, A. J.; Vacante, D. A.; Deane, E. F. Size Exclusion Removal of Model Mammalian Viruses Using a Unique Membrane System, Part I: Membrane Qualification. Biologicals. 1993, 21, 275-286.
-
(1993)
Biologicals
, vol.21
, pp. 275-286
-
-
DiLeo, A.J.1
Vacante, D.A.2
Deane, E.F.3
-
17
-
-
0029150647
-
Improved Virus Safety and Purity of a Chromatographically Produced Factor IX Concentrate by Nanofiltration
-
Hoffer, L.; Schwinn, H.; Biesert, L.; Josic, D. Improved Virus Safety and Purity of a Chromatographically Produced Factor IX Concentrate by Nanofiltration. J. Chromatogr. B: Biomed. Sci. Appl. 1995, 669, 187-196.
-
(1995)
J. Chromatogr. B: Biomed. Sci. Appl
, vol.669
, pp. 187-196
-
-
Hoffer, L.1
Schwinn, H.2
Biesert, L.3
Josic, D.4
-
18
-
-
0003101698
-
Filtration and Removal of Viruses from Biopharmaceuticals
-
Meltzer, T, Jornitz, M, Eds, Marcel Dekker, Inc, New York
-
Levy R.; Philips, M.; Lutz, H. Filtration and Removal of Viruses from Biopharmaceuticals. In Filtration in the Biopharmaceutical Industry; Meltzer, T.; Jornitz, M., Eds.; Marcel Dekker, Inc.: New York. 1998; pp 619-646.
-
(1998)
Filtration in the Biopharmaceutical Industry
, pp. 619-646
-
-
Levy, R.1
Philips, M.2
Lutz, H.3
-
19
-
-
0030333184
-
Removal of Virus Through Novel Membrane Filtration Method
-
Manabe, S. Removal of Virus Through Novel Membrane Filtration Method. Dev. Biol. Stand. 1996, 88, 81-90.
-
(1996)
Dev. Biol. Stand
, vol.88
, pp. 81-90
-
-
Manabe, S.1
-
20
-
-
0030341860
-
Virus Removal Studies Using Nanofiltration Membranes
-
Brown, F, Lubiniecki, A, Eds, Karger: Basel, Switzerland
-
O'Grady, J.; Losikoff, A.; Poiley, J.; Fickett, D.; Oliver, C. Virus Removal Studies Using Nanofiltration Membranes. In Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products; Brown, F.; Lubiniecki, A., Eds.; Karger: Basel, Switzerland, 1996; pp 319-326.
-
(1996)
Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products
, pp. 319-326
-
-
O'Grady, J.1
Losikoff, A.2
Poiley, J.3
Fickett, D.4
Oliver, C.5
-
21
-
-
0032452398
-
Removal of Viruses from Human Intravenous Immune Globulin by 35 nm Nanofiltration
-
Troccoli, N. M.; McIver, J.; Losikoff, A.; Poiley, J. Removal of Viruses from Human Intravenous Immune Globulin by 35 nm Nanofiltration. Biologicals. 1998, 26, 321-329.
-
(1998)
Biologicals
, vol.26
, pp. 321-329
-
-
Troccoli, N.M.1
McIver, J.2
Losikoff, A.3
Poiley, J.4
-
22
-
-
0024702469
-
Particle Capture Mechanisms in Gases and Liquids: An Analysis of Operative Mechanisms
-
Grant, D. C.; Liu, B. Y. H.; Fischer, W. G.; Bowling, R. A. Particle Capture Mechanisms in Gases and Liquids: An Analysis of Operative Mechanisms. J. Environ. Sci. 1989, 42 (4), pp 43-51.
-
(1989)
J. Environ. Sci
, vol.42
, Issue.4
, pp. 43-51
-
-
Grant, D.C.1
Liu, B.Y.H.2
Fischer, W.G.3
Bowling, R.A.4
-
23
-
-
34547686256
-
Phage Passage after Extended Processing in Small-Virus-Retentive Filters
-
Lute, S.; Bailey M.; Combs, J.; Sukumar, M.; Brorson, K. Phage Passage after Extended Processing in Small-Virus-Retentive Filters. Biotechnol. Appl. Biochem. 2007, 47 (Pt 3), 141-151.
-
(2007)
Biotechnol. Appl. Biochem
, vol.47
, Issue.PART 3
, pp. 141-151
-
-
Lute, S.1
Bailey, M.2
Combs, J.3
Sukumar, M.4
Brorson, K.5
-
24
-
-
0036021996
-
Performance of a Novel Viresolve NFR Virus Filter
-
Brough, H.; Antoniou, C.; Carter, J.; Jakubik, J.; Xu, Y.; Lutz, H. Performance of a Novel Viresolve NFR Virus Filter. Biotechnol. Prog. 2002, 18, 782-795.
-
(2002)
Biotechnol. Prog
, vol.18
, pp. 782-795
-
-
Brough, H.1
Antoniou, C.2
Carter, J.3
Jakubik, J.4
Xu, Y.5
Lutz, H.6
-
25
-
-
25144484795
-
Normal-Flow Virus Filtration: Detection and Assessment of the Endpoint in Bio-Processing
-
Bolton, G.; Cabatingan, M.; Rubino, M.; Lute, S.; Brorson, K.; Bailey M. Normal-Flow Virus Filtration: Detection and Assessment of the Endpoint in Bio-Processing. Biotechnol. Appl. Biochem. 2005, 42 (Pt 2), 133-142.
-
(2005)
Biotechnol. Appl. Biochem
, vol.42
, Issue.PART 2
, pp. 133-142
-
-
Bolton, G.1
Cabatingan, M.2
Rubino, M.3
Lute, S.4
Brorson, K.5
Bailey, M.6
-
26
-
-
0028721435
-
Mechanism of Removing Japanese Encephalitis Virus (Lev) and Gold Particles using Cuprammonium Regenerated Cellulose Hollow Fiber (I-BMM Or BMM) from Aqueous Solution Containing Protein
-
Hirasaki, T.; Nakano, H.; Ishizaki, Y.; Manabe, S.; Yamamoto, N. Mechanism of Removing Japanese Encephalitis Virus (Lev) and Gold Particles using Cuprammonium Regenerated Cellulose Hollow Fiber (I-BMM Or BMM) from Aqueous Solution Containing Protein. Polym. J. 1994, 26, 1244-1256.
-
(1994)
Polym. J
, vol.26
, pp. 1244-1256
-
-
Hirasaki, T.1
Nakano, H.2
Ishizaki, Y.3
Manabe, S.4
Yamamoto, N.5
-
27
-
-
0005655245
-
The Structure and Infective Process of a Pseudomonas Aeruginosa Bacteriophage containing Ribonucleic Acid
-
Bradley D. The Structure and Infective Process of a Pseudomonas Aeruginosa Bacteriophage containing Ribonucleic Acid. J. Gen. Microbiol. 1966, 45, 83-96.
-
(1966)
J. Gen. Microbiol
, vol.45
, pp. 83-96
-
-
Bradley, D.1
-
28
-
-
0018348172
-
Properties of R Plasmid R772 and the Corresponding Pilus-specific Phage PR772
-
Coetzee,J. N.; Lecatsas, G.; Coetzee, W. F.; Hedges, R. W. Properties of R Plasmid R772 and the Corresponding Pilus-specific Phage PR772. J. Gen. Microbiol. 1979, 110, 263-273.
-
(1979)
J. Gen. Microbiol
, vol.110
, pp. 263-273
-
-
Coetzee, J.N.1
Lecatsas, G.2
Coetzee, W.F.3
Hedges, R.W.4
-
29
-
-
0018733888
-
Pilus-specific, Lipid-containing Bacteriophages PR4 and PR772: Comparison of Physical Characteristics of Genomes
-
Coetzee, W. F.; Bekker, P. J. Pilus-specific, Lipid-containing Bacteriophages PR4 and PR772: Comparison of Physical Characteristics of Genomes. J. Gen. Virol. 1979, 45, 195-200.
-
(1979)
J. Gen. Virol
, vol.45
, pp. 195-200
-
-
Coetzee, W.F.1
Bekker, P.J.2
-
30
-
-
0028852550
-
Nucleotide Sequence of a Single-stranded RNA Phage from Pseudomonas Aeruginosa: Kinship to Coliphages and Conservation of Regulatory RNA Structures
-
Olsthoorn, R. C.; Garde, G.; Dayhuff, T.; Atkins, J. F.; Van Duin, J. Nucleotide Sequence of a Single-stranded RNA Phage from Pseudomonas Aeruginosa: Kinship to Coliphages and Conservation of Regulatory RNA Structures. Virology. 1995, 206, 611-625.
-
(1995)
Virology
, vol.206
, pp. 611-625
-
-
Olsthoorn, R.C.1
Garde, G.2
Dayhuff, T.3
Atkins, J.F.4
Van Duin, J.5
-
31
-
-
4143087341
-
Characterization of Coliphage PR772 and Evaluation of its use for Virus Filter Performance Testing
-
Lute, S.; Aranha, H.; Tremblay, D.; Liang, D.; Ackermann, H. W.; Chu, B.; Moineau, S.; Brorson, K. Characterization of Coliphage PR772 and Evaluation of its use for Virus Filter Performance Testing. Appl. Environ. Microbiol. 2004, 70, 4864-4871.
-
(2004)
Appl. Environ. Microbiol
, vol.70
, pp. 4864-4871
-
-
Lute, S.1
Aranha, H.2
Tremblay, D.3
Liang, D.4
Ackermann, H.W.5
Chu, B.6
Moineau, S.7
Brorson, K.8
-
32
-
-
57649230103
-
A Consensus Rating Method for Small Virus Retentive Filters. II, Method Evaluation
-
Brorson, K.; Lute, S.; Haque, M.; Sato, T.; Moroe, I.; Morgan, M.; Krishnan, M.; Campbell J.; Genest, P.; Parrella, J.; Dolan, S.; Martin, S. A Consensus Rating Method for Small Virus Retentive Filters. II, Method Evaluation. PDA J. Pharm. Sci. Technol. 2008, 62, 334-343.
-
(2008)
PDA J. Pharm. Sci. Technol
, vol.62
, pp. 334-343
-
-
Brorson, K.1
Lute, S.2
Haque, M.3
Sato, T.4
Moroe, I.5
Morgan, M.6
Krishnan, M.7
Campbell, J.8
Genest, P.9
Parrella, J.10
Dolan, S.11
Martin, S.12
-
33
-
-
30344451379
-
Nomenclature Standardization for 'Large Pore Size' Virus-Retentive Filters
-
Brorson, K.; Sofer, G.; Aranha, H.; Nomenclature Standardization for 'Large Pore Size' Virus-Retentive Filters. PDA J. Pharm. Sci. Technol. 2005, 59, 341-345.
-
(2005)
PDA J. Pharm. Sci. Technol
, vol.59
, pp. 341-345
-
-
Brorson, K.1
Sofer, G.2
Aranha, H.3
-
34
-
-
23244446008
-
Large Pore Size Virus Filter Test Method Recommended by the PDA Virus Filter Task Force
-
Brorson, K.; Sofer, G.; Robertson, G.; Lute, S.; Martin, J.; Aranha, H.; Haque, M.; Satoh, S. Yoshinari, K.; Moroe, I.; et.al. "Large Pore Size" Virus Filter Test Method Recommended by the PDA Virus Filter Task Force. PDA J Pharm. Sci. Technol. 2005, 59, 177-186.
-
(2005)
PDA J Pharm. Sci. Technol
, vol.59
, pp. 177-186
-
-
Brorson, K.1
Sofer, G.2
Robertson, G.3
Lute, S.4
Martin, J.5
Aranha, H.6
Haque, M.7
Satoh, S.8
Yoshinari, K.9
Moroe, I.10
-
35
-
-
0032548914
-
Electrostatic Effects on Protein Partitioning in Size-Exclusion Chromatography and Membrane Ultrafiltration
-
Pujar, N. S.; Zydney A. L. Electrostatic Effects on Protein Partitioning in Size-Exclusion Chromatography and Membrane Ultrafiltration. J. Chromatogr. A. 1998 796, 229-238.
-
(1998)
J. Chromatogr. A
, vol.796
, pp. 229-238
-
-
Pujar, N.S.1
Zydney, A.L.2
-
37
-
-
27144466989
-
Validation of Virus Filtration: Ensuring Regulatory Compliance
-
Carter, J.; Lutz, H. Validation of Virus Filtration: Ensuring Regulatory Compliance. BioPro. Intl. 2003, 1(1), 52-62.
-
(2003)
BioPro. Intl
, vol.1
, Issue.1
, pp. 52-62
-
-
Carter, J.1
Lutz, H.2
-
38
-
-
57649212020
-
A Consensus Rating Method for Small Virus Retentive Filters. I. Method Development
-
Lute, S.; Riordan, W.; Pease, L.; Tsai, D.; Levy R.; Haque, M.; Moroe, I.; Sato, T.; Morgan, M.; Krishnan, M.; et al. A Consensus Rating Method for Small Virus Retentive Filters. I. Method Development. PDA J. Pharm. Sci. Technol. 2008, 62, 318-333.
-
(2008)
PDA J. Pharm. Sci. Technol
, vol.62
, pp. 318-333
-
-
Lute, S.1
Riordan, W.2
Pease, L.3
Tsai, D.4
Levy, R.5
Haque, M.6
Moroe, I.7
Sato, T.8
Morgan, M.9
Krishnan, M.10
-
39
-
-
0031792104
-
Comparison of Filtration Properties of Hepatitis B Virus, Hepatitis C Virus and Simian Virus 40 Using a Polyvinylidene Fluoride Membrane Filter
-
Oshima, K. H.; Evans-Strickfaden, T.; Highsmith, A. Comparison of Filtration Properties of Hepatitis B Virus, Hepatitis C Virus and Simian Virus 40 Using a Polyvinylidene Fluoride Membrane Filter. Vox Sang. 1998, 75, 181-188.
-
(1998)
Vox Sang
, vol.75
, pp. 181-188
-
-
Oshima, K.H.1
Evans-Strickfaden, T.2
Highsmith, A.3
-
40
-
-
0030175036
-
The Use of a Microporous Polyvinylidene Fluoride (PVDF) Membrane Filter to Separate Contaminating Viral Particles from Biologically Important Proteins
-
Oshima, K. H.; Evans-Strickfaden, T.; Highsmith, A.; Ades, E. The Use of a Microporous Polyvinylidene Fluoride (PVDF) Membrane Filter to Separate Contaminating Viral Particles from Biologically Important Proteins. Biologicals. 1996, 24, 137-145.
-
(1996)
Biologicals
, vol.24
, pp. 137-145
-
-
Oshima, K.H.1
Evans-Strickfaden, T.2
Highsmith, A.3
Ades, E.4
-
41
-
-
0017803555
-
The Size Of The Bacteriophage T4 Head in Solution with Comments about the Dimension of Virus Particles as Visualized by Electron Microscopy
-
Earnshaw, W. C.; King, J.; Eiserling, F. A. The Size Of The Bacteriophage T4 Head in Solution with Comments about the Dimension of Virus Particles as Visualized by Electron Microscopy. J. Mol. Biol. 1978, 122, 247-253.
-
(1978)
J. Mol. Biol
, vol.122
, pp. 247-253
-
-
Earnshaw, W.C.1
King, J.2
Eiserling, F.A.3
-
42
-
-
27144474696
-
Factors Influencing Virus Removal and Product Yield During Nanofiltration of Highly Purified Plasma Derived Protein with Thrombolytic Activity
-
Korneyeva, M.; Charles, P.; Li, H.; McNaull, S.; Smith, S.; Petteway S.; Pifat, D. Factors Influencing Virus Removal and Product Yield During Nanofiltration of Highly Purified Plasma Derived Protein with Thrombolytic Activity. Int. J. Hematol. 2002, 76 (Sup. 1), 29.
-
(2002)
Int. J. Hematol
, vol.76
, Issue.SUP. 1
, pp. 29
-
-
Korneyeva, M.1
Charles, P.2
Li, H.3
McNaull, S.4
Smith, S.5
Petteway, S.6
Pifat, D.7
-
43
-
-
2342629243
-
An Overview Of Quantitative PCR Assays For Biologicals: Quality And Safety Evaluation
-
Xu, Y.; Brorson, K. An Overview Of Quantitative PCR Assays For Biologicals: Quality And Safety Evaluation. Dev. Biol. 2003, 113, 89-98.
-
(2003)
Dev. Biol
, vol.113
, pp. 89-98
-
-
Xu, Y.1
Brorson, K.2
-
44
-
-
57749112597
-
-
Quality Guideline Q2(R1): Validation of Analytical Procedures: Text and Methodology; International Conference on Harmonisation: 2005.
-
Quality Guideline Q2(R1): Validation of Analytical Procedures: Text and Methodology; International Conference on Harmonisation: 2005.
-
-
-
-
45
-
-
57749085103
-
-
Quality Guideline Q8: Pharmaceutical Development; International Conference on Harmonisation: 2005.
-
Quality Guideline Q8: Pharmaceutical Development; International Conference on Harmonisation: 2005.
-
-
-
|