Process Validation in Manufacturing of Biopharmaceuticals
portes grátis
Process Validation in Manufacturing of Biopharmaceuticals
Rudge, Scott; Singh Rathore, Anurag; Baseman, Hal
Taylor & Francis Ltd
12/2023
392
Dura
Inglês
9780367697624
15 a 20 dias
Descrição não disponível.
The Evolution of Modern Process Validation: Commentary on the U.S. Food and Drug Administration's 2011 Guidance for Industry, Process Validation Principles and Practices
Hal Baseman
Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes
Robert J. Seely and John Haury
Process Characterization
James E. Seely
Scale-Down Models for Microbial and Mammalian Cell Culture Processes: Approaches and Applications
Ravali Raju et al.
Scale-Down Models for Purification Processes: Approaches and Application
Arch Creasy et al.
Principles of Quality Risk Management for Validation
Tiffany Baker and Patrick Mains
Lifespan Studies for Chromatography and Filtration Media
Anurag S. Rathore and Gail Sofer
Analytical Test Methods for Well-Characterized Biological and Biotechnological Products
Nadine Ritter and John McEntire
Adventitious Agents: Concerns and Testing for Biopharmaceuticals
Raymond W. Nims et al.
Biotech Facility Design for Validation
Phil DeSantis
Process Validation at Contract Manufacturing Organizations: Approaches, Incentives, Benefits, and Risks
Maria Wik and Scott Rudge
Validation of a Filtration Step
Jennifer Campbell et al.
Validation of Continuous Bioprocesses
Marc Bisschops and Mark Schofield
Role of Multivariate Analysis in Process Validation
Anurag S. Rathore and Vishwanath Hebbi
Process Development for Plasmid DNA Production
Frank Agbogdo et al.
Hal Baseman
Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes
Robert J. Seely and John Haury
Process Characterization
James E. Seely
Scale-Down Models for Microbial and Mammalian Cell Culture Processes: Approaches and Applications
Ravali Raju et al.
Scale-Down Models for Purification Processes: Approaches and Application
Arch Creasy et al.
Principles of Quality Risk Management for Validation
Tiffany Baker and Patrick Mains
Lifespan Studies for Chromatography and Filtration Media
Anurag S. Rathore and Gail Sofer
Analytical Test Methods for Well-Characterized Biological and Biotechnological Products
Nadine Ritter and John McEntire
Adventitious Agents: Concerns and Testing for Biopharmaceuticals
Raymond W. Nims et al.
Biotech Facility Design for Validation
Phil DeSantis
Process Validation at Contract Manufacturing Organizations: Approaches, Incentives, Benefits, and Risks
Maria Wik and Scott Rudge
Validation of a Filtration Step
Jennifer Campbell et al.
Validation of Continuous Bioprocesses
Marc Bisschops and Mark Schofield
Role of Multivariate Analysis in Process Validation
Anurag S. Rathore and Vishwanath Hebbi
Process Development for Plasmid DNA Production
Frank Agbogdo et al.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
bioprocess engineering;quality risk management;failure modes analysis;scale-down modelling;chromatography techniques;analytical test methods;continuous bioprocess validation
The Evolution of Modern Process Validation: Commentary on the U.S. Food and Drug Administration's 2011 Guidance for Industry, Process Validation Principles and Practices
Hal Baseman
Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes
Robert J. Seely and John Haury
Process Characterization
James E. Seely
Scale-Down Models for Microbial and Mammalian Cell Culture Processes: Approaches and Applications
Ravali Raju et al.
Scale-Down Models for Purification Processes: Approaches and Application
Arch Creasy et al.
Principles of Quality Risk Management for Validation
Tiffany Baker and Patrick Mains
Lifespan Studies for Chromatography and Filtration Media
Anurag S. Rathore and Gail Sofer
Analytical Test Methods for Well-Characterized Biological and Biotechnological Products
Nadine Ritter and John McEntire
Adventitious Agents: Concerns and Testing for Biopharmaceuticals
Raymond W. Nims et al.
Biotech Facility Design for Validation
Phil DeSantis
Process Validation at Contract Manufacturing Organizations: Approaches, Incentives, Benefits, and Risks
Maria Wik and Scott Rudge
Validation of a Filtration Step
Jennifer Campbell et al.
Validation of Continuous Bioprocesses
Marc Bisschops and Mark Schofield
Role of Multivariate Analysis in Process Validation
Anurag S. Rathore and Vishwanath Hebbi
Process Development for Plasmid DNA Production
Frank Agbogdo et al.
Hal Baseman
Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes
Robert J. Seely and John Haury
Process Characterization
James E. Seely
Scale-Down Models for Microbial and Mammalian Cell Culture Processes: Approaches and Applications
Ravali Raju et al.
Scale-Down Models for Purification Processes: Approaches and Application
Arch Creasy et al.
Principles of Quality Risk Management for Validation
Tiffany Baker and Patrick Mains
Lifespan Studies for Chromatography and Filtration Media
Anurag S. Rathore and Gail Sofer
Analytical Test Methods for Well-Characterized Biological and Biotechnological Products
Nadine Ritter and John McEntire
Adventitious Agents: Concerns and Testing for Biopharmaceuticals
Raymond W. Nims et al.
Biotech Facility Design for Validation
Phil DeSantis
Process Validation at Contract Manufacturing Organizations: Approaches, Incentives, Benefits, and Risks
Maria Wik and Scott Rudge
Validation of a Filtration Step
Jennifer Campbell et al.
Validation of Continuous Bioprocesses
Marc Bisschops and Mark Schofield
Role of Multivariate Analysis in Process Validation
Anurag S. Rathore and Vishwanath Hebbi
Process Development for Plasmid DNA Production
Frank Agbogdo et al.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
