Viral Clearance

Using Retrovirus-Like Particles for Downstream Viral-Clearance Evaluation: Implications of the 2022 ICH Q5A Revision
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Using Retrovirus-Like Particles for Downstream Viral-Clearance Evaluation: Implications of the 2022 ICH Q5A RevisionUsing Retrovirus-Like Particles for Downstream Viral-Clearance Evaluation: Implications of the 2022 ICH Q5A Revision

byDavid Cetlin
Nov 16, 2023
Shaping the Future of Viral Clearance: Analyzing ICH Q5A(R2) and Its Impacts
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Shaping the Future of Viral Clearance: Analyzing ICH Q5A(R2) and Its ImpactsShaping the Future of Viral Clearance: Analyzing ICH Q5A(R2) and Its Impacts
byTareq Z. Jaber, Anja Tessarz
Jul 18, 2023
Using CHO-Endogenous RVLPs for Retroviral Clearance Studies
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Using CHO-Endogenous RVLPs for Retroviral Clearance StudiesUsing CHO-Endogenous RVLPs for Retroviral Clearance Studies
byDavid Cetlin, Alla Zilberman
Jun 26, 2023
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Understanding Viral Clearance During Anion-Exchange Chromatography: A Novel Design of Experiments ApproachUnderstanding Viral Clearance During Anion-Exchange Chromatography: A Novel Design of Experiments Approach
byMoira Lynch, Zhijun (George) Tanand 4 more
Jun 2, 2023
Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance
Viral Clearance
Viral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive GuidanceViral Safety for Biotechnology Products, Including Viral Vectors: ICH Q5A Revision 2 Brings Updated and More Comprehensive Guidance
byDavid Perez-Caballero, David Murrayand 2 more
May 17, 2023
Introduction: Viral Clearance and Inactivation in Downstream Processing
Viral Clearance
Introduction: Viral Clearance and Inactivation in Downstream ProcessingIntroduction: Viral Clearance and Inactivation in Downstream Processing
byCheryl Scott
Dec 12, 2022
Triton X-100 Elimination: The Road Ahead for Viral Inactivation
Viral Clearance
Triton X-100 Elimination: The Road Ahead for Viral Inactivation
Triton X-100 Elimination: The Road Ahead for Viral Inactivation
Dec 12, 2022
byKurt Brorson, Christiane Niederlaender
Worst-Case Conditions for Viral Clearance
Viral Clearance
Worst-Case Conditions for Viral Clearance
Worst-Case Conditions for Viral Clearance
Dec 12, 2022
+7
byDhiral A. Shah, James Berrieand 7 more
Hollow-Fiber Nanofiltration for Robust Viral Clearance of Non-MAb Biologics
Filtration
Hollow-Fiber Nanofiltration for Robust Viral Clearance of Non-MAb Biologics
Hollow-Fiber Nanofiltration for Robust Viral Clearance of Non-MAb Biologics
Dec 12, 2022
+5
byJi Zheng, Jessica A. Wallerand 5 more
Comprehensive Virus Clearance Evaluation Using Microscale Membrane Adsorbers logo in a gray background | Comprehensive Virus Clearance Evaluation Using Microscale Membrane Adsorbers
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Comprehensive Virus Clearance Evaluation Using Microscale Membrane Adsorbers
Comprehensive Virus Clearance Evaluation Using Microscale Membrane Adsorbers
Sep 28, 2022
bySherri Dolan
The Impact of Protein Stability on Virus Filtration
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The Impact of Protein Stability on Virus Filtration
The Impact of Protein Stability on Virus Filtration
Apr 28, 2022
+1
byDaniel A. Eshete, Ian Johnsonand 1 more
Viral Safety of Viral Vectors:<br> Special Concerns Arise When the Virus Is the Product
Viral Clearance
Viral Safety of Viral Vectors: Special Concerns Arise When the Virus Is the Product
Viral Safety of Viral Vectors: Special Concerns Arise When the Virus Is the Product
Oct 29, 2021
byCheryl Scott, Hazel Aranha
MAb Viral Clearance Studies: <br>A Substantiated Platform Approach for the IND Stage
Viral Clearance
MAb Viral Clearance Studies: A Substantiated Platform Approach for the IND Stage
MAb Viral Clearance Studies: A Substantiated Platform Approach for the IND Stage
Oct 28, 2021
+3
byCai Bao, Mayank Sainiand 3 more
Predicting Viral Clearance in Downstream Process Development
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Predicting Viral Clearance in Downstream Process Development
Predicting Viral Clearance in Downstream Process Development
May 27, 2021
byDavid Cetlin
Virus Assay Variation Is the Main Source of Variation in Viral Clearance Studies: Retrospective Analysis of a Large Data Set
Viral Clearance
Virus Assay Variation Is the Main Source of Variation in Viral Clearance Studies: Retrospective Analysis of a Large Data Set
Virus Assay Variation Is the Main Source of Variation in Viral Clearance Studies: Retrospective Analysis of a Large Data Set
Apr 16, 2021
bySøren Kamstrup, J. L. Thomsen
Viral Clearance in a Downstream AAV Process: Case Study Using a Model Virus Panel and a Noninfectious Surrogate
Viral Clearance
Viral Clearance in a Downstream AAV Process: Case Study Using a Model Virus Panel and a Noninfectious Surrogate
Viral Clearance in a Downstream AAV Process: Case Study Using a Model Virus Panel and a Noninfectious Surrogate
Apr 16, 2021
+12
byMichael Winkler, Mikhail Goldfarband 12 more
Customized Yeast HCP Quantification with Biolayer Interferometry Using a Horseradish Peroxidase Substrate
QA/QC
Customized Yeast HCP Quantification with Biolayer Interferometry Using a Horseradish Peroxidase Substrate
Customized Yeast HCP Quantification with Biolayer Interferometry Using a Horseradish Peroxidase Substrate
Mar 9, 2021
+1
byEva Sjõblom, Karen Duusand 1 more
Ask the Expert: Predicting Viral Clearance During Downstream Development
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Ask the Expert: Predicting Viral Clearance During Downstream Development
Ask the Expert: Predicting Viral Clearance During Downstream Development
Dec 17, 2020
byBPI Contributor
How Much Harm Can a Single Droplet Do? Considerations for a Viral Inactivation Step
Viral Clearance
How Much Harm Can a Single Droplet Do? Considerations for a Viral Inactivation Step
How Much Harm Can a Single Droplet Do? Considerations for a Viral Inactivation Step
Oct 29, 2020
+6
bySøren Kamstrup, Eva Synnestvedt Hansenand 6 more
Streamlined Polishing and Viral Clearance Using a New Hybrid, Biomimetic, Single-Use Anion Exchanger
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Streamlined Polishing and Viral Clearance Using a New Hybrid, Biomimetic, Single-Use Anion Exchanger
Streamlined Polishing and Viral Clearance Using a New Hybrid, Biomimetic, Single-Use Anion Exchanger
Oct 29, 2020
+3
byJonathan F. Hester, Jennifer Heitkampand 3 more
A Challenge in Viral Clearance Determination: Estimation of Fifty-Percent Tissue Culture Infective Dose (TCID<sub>50</sub>) for Low Virus
Viral Clearance
A Challenge in Viral Clearance Determination: Estimation of Fifty-Percent Tissue Culture Infective Dose (TCID50) for Low Virus Concentrations
A Challenge in Viral Clearance Determination: Estimation of Fifty-Percent Tissue Culture Infective Dose (TCID50) for Low Virus Concentrations
May 24, 2020
byAnne Charlotte Arentsen, Søren Kamstrup
A Response Plan for Viral Contamination in Bioproduction Facilities
Viral Clearance
A Response Plan for Viral Contamination in Bioproduction Facilities
A Response Plan for Viral Contamination in Bioproduction Facilities
Mar 3, 2020
byYuval Shimoni
Detection and Clearance of Viruses in the Biopharmaceutical Industry
Viral Clearance
Detection and Clearance of Viruses in the Biopharmaceutical Industry
Detection and Clearance of Viruses in the Biopharmaceutical Industry
Dec 17, 2019
byShada Warreth
Modeling Virus Clearance: Use of a Noninfectious Surrogate of Mouse Minute Virus As a Tool for Evaluating an Anion-Exchange Chromatography Method
Viral Clearance
Modeling Virus Clearance: Use of a Noninfectious Surrogate of Mouse Minute Virus As a Tool for Evaluating an Anion-Exchange Chromatography Method
Modeling Virus Clearance: Use of a Noninfectious Surrogate of Mouse Minute Virus As a Tool for Evaluating an Anion-Exchange Chromatography Method
May 17, 2019
+4
byKevin Herbig, David Cetlinand 4 more
The Complete e-Book of Biosafety Testing
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The Complete e-Book of Biosafety Testing
The Complete e-Book of Biosafety Testing
Dec 12, 2018
byBPI Contributor
Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant
Viral Clearance
Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant
Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant
Nov 10, 2018
byCheryl Scott
Viral Risk Mitigation: A Global Regulatory Perspective
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Viral Risk Mitigation: A Global Regulatory Perspective
Viral Risk Mitigation: A Global Regulatory Perspective
Oct 30, 2018
byMartin Wisher
Virus Segregation During Purification Processes: Calculation of Critical Potential Carryover of Viruses
Viral Clearance
Virus Segregation During Purification Processes: Calculation of Critical Potential Carryover of Viruses
Virus Segregation During Purification Processes: Calculation of Critical Potential Carryover of Viruses
Sep 15, 2018
+1
byPer Kærsgaard, Søren Kamstrupand 1 more
Advanced Viral Clearance Study Design: A Total Viral Challenge Approach to Virus Filtration
Viral Clearance
Advanced Viral Clearance Study Design: A Total Viral Challenge Approach to Virus Filtration
Advanced Viral Clearance Study Design: A Total Viral Challenge Approach to Virus Filtration
Mar 23, 2018
+6
byMichael Burnham, Alexander Schwartzand 6 more
Evaluating Adsorptive Filtration As a Unit Operation for Virus Removal
Viral Clearance
Evaluating Adsorptive Filtration As a Unit Operation for Virus Removal
Evaluating Adsorptive Filtration As a Unit Operation for Virus Removal
Mar 23, 2018
+6
byAnja Trapp, Sophie Muczenskiand 6 more
Current Thinking in Viral Safety: Risk Management Protects Patients logo in a gray background | Current Thinking in Viral Safety: Risk Management Protects Patients
Viral Clearance
Current Thinking in Viral Safety: Risk Management Protects Patients
Current Thinking in Viral Safety: Risk Management Protects Patients
May 18, 2017
+1
byHazel Aranha, S. Anne Montgomeryand 1 more
Viral Clearance in Antibody Purification Using Tentacle Ion Exchangers
Viral Clearance
Viral Clearance in Antibody Purification Using Tentacle Ion Exchangers
Viral Clearance in Antibody Purification Using Tentacle Ion Exchangers
Oct 14, 2016
+1
byLars H. Peeck, Estelle Zelterand 1 more
Virus-Filtration Process Development Optimization: The Key to a More Efficient and Cost-Effective Step
Viral Clearance
Virus-Filtration Process Development Optimization: The Key to a More Efficient and Cost-Effective Step
Virus-Filtration Process Development Optimization: The Key to a More Efficient and Cost-Effective Step
Apr 12, 2016
+1
byJaime De Souza, Ken Scottand 1 more
Identification and Quantification of Heat-Shock Protein 70: A Major Host-Cell Protein Contaminant from HEK Host Cells
Viral Clearance
Identification and Quantification of Heat-Shock Protein 70: A Major Host-Cell Protein Contaminant from HEK Host Cells
Identification and Quantification of Heat-Shock Protein 70: A Major Host-Cell Protein Contaminant from HEK Host Cells
Oct 15, 2015
+6
byXiaohui Lu, Chong-Feng Xuand 6 more
Fundamental Strategies for Viral Clearance Part 2: Technical Approaches
Viral Clearance
Fundamental Strategies for Viral Clearance Part 2: Technical Approaches
Fundamental Strategies for Viral Clearance Part 2: Technical Approaches
May 12, 2015
byKathryn Martin Remington

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Monitoring and Controlling Upstream Bioprocesses with Raman Spectroscopy

Dec 1, 2024

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Peptones: A Powerful Tool for Manufacturing Complex Protein Therapies
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Nov 21, 2024

Thermo Fisher WP
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Efficient-Pro Medium and Feed 1 Enable Rapid and Seamless Upstream Process Development and Scale-Up for CHO-K1 Cells
Efficient-Pro Medium and Feed 1 Enable Rapid and Seamless Upstream Process Development and Scale-Up for CHO-K1 Cells

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