1st Edition
Separations Technology Pharmaceutical and Biotechnology Applications
Edited By Wayne P. Olson
Copyright 1995
576 Pages
by
CRC Press
576 Pages
by
CRC Press
Also available as eBook on:
Authored by a team of respected scientists and technologists, this book covers many pharmaceutical and biotechnology separations methods currently in use. Practical applications and descriptions are offered for air elutriation, microporous filtration, ultrafiltration, phase partitioning, crystallization, and chromatographic technologies such as adsorption, affinity, chelate, ion-exchange, size-exclusion, template, hydrophobic interaction, biotransformations, and chiral separations.
Containing hundreds of references and a complete index, this book is designed for research and development scientists, process optimization engineers, and quality control laboratory scientists as well as quality assurance professionals and others needing to understand current separation techniques.
Separations in Pharmaceutical Manufacturing, Wayne P. Olson
Pure Drugs v. Crude Preparations: Conventional Pharmaceuticals v. Folk Medicine
Developing a Drug (Apart from Regulatory Issues)
Sizing a Chromatographic System
Purification Methods
Purification Steps and Yield
Isolators
Scaleup from a Published Bench Method
Automation
References
Membrane Pervaporation, Timothy deVilliers Naylor
Principles of Pervaporation
Factors Affecting Membrane Performance
Energy Requirements
Application Opportunities
Conclusions
References
Tangential Flow Filtration, Stephen L. Michaels, et al.
The History of Tangential Flow Filtration
Principles and Theory
Tangential Flow Filtration Equipment
Application Classes in Pharmaceutical Separations
Principles of Tangential Flow Filtration Maintenance
Principles of Tangential Flow Filtration Validation and Qualification
References
Recommended Reading
Supercritical Fluid Extraction/Chromatography
Kent M. Payne, Jerry W. King
Theory
Applications of Supercritical Fluids
Supercritical Process Equipments
Conclusion
References
Preparative Separation of Enantiomers, Charles M. Grill, John R. Kern, Scott R. Perrin
Practical Aspects
Optimization Strategy
Preparative Chromatographic Resolution of the ยต-Burke Olefin
Resolution of Racemates by Closed Loop Recycling Chromatography
Continuous Preparative Techniques for Resolving Racemic Mixtures
New Techniques
References
Chromatographic Purification of Recombinant Protein Products, Eugene P. Kroeff
Purification Challenges
System Selectivity
Process Reproducibility
Process Scaleup Considerations
Examples of Chromatographic Purification of rDNA Products
Summary
References
Affinity Chromatography, Wayne P. Olson
Definitions
Origins of Affinity Separations
Affinity Pairs: Examples
Matrices of Choice
Ligand Immobilization Chemistries
Elution Strategies
Analysis of the Products
References
Monoclonal Antibodies, Gary Christiansen
Definitions
Historical Notes
The Production of Monoclonal Antibodies
Purification Objectives and Goals
Purification Methods
Recent Advances and Future Trends
Conclusions
References
Immunoaffinity Purification of Proteins for Injection, and the Issue of Animal Viruses, Wayne P. Olson
Immobilized Antigens and Antibodies - A Research Tool
Immunosorbents for the Purification of Human Clotting Factor VIII for Injection
The Issue of Virus Elimination and/or Destruction
Preferred Methods for Antibody Immobilization
Scaling from the Limiting Step in Process
Charging and Eluting the Column
Issues with Immobilized Antibodies
Automation of the Cycle
Cell Purification with Immobilized Antibodies
Comparison of Immunosorbent with Other Methods
References
Process Validation of Separation Systems, Steven S. Kuwahara, Jane H. Chuan
Types of Validation
Why Validate?
Who, What, and Where to Conduct Validations
Extent of Validations
General Considerations
Getting Started: What Needs to Be in Place Before Beginning Your Validation
Separation Systems
References
A Salute to the Human Plasma Processing Industry and Its Founders, E.J. Cohn et al., Robert Tenold
Fractionation Automation
Centrifuges
Filters and Process Filter Media
Wiped or Thin Film Evaporation Systems
Screen Systems
Ultrafiltration/Diafiltration
Gel Chromatography
Lyophilization
Putting Out Fires
Acknowledgments
References
Index
Pure Drugs v. Crude Preparations: Conventional Pharmaceuticals v. Folk Medicine
Developing a Drug (Apart from Regulatory Issues)
Sizing a Chromatographic System
Purification Methods
Purification Steps and Yield
Isolators
Scaleup from a Published Bench Method
Automation
References
Membrane Pervaporation, Timothy deVilliers Naylor
Principles of Pervaporation
Factors Affecting Membrane Performance
Energy Requirements
Application Opportunities
Conclusions
References
Tangential Flow Filtration, Stephen L. Michaels, et al.
The History of Tangential Flow Filtration
Principles and Theory
Tangential Flow Filtration Equipment
Application Classes in Pharmaceutical Separations
Principles of Tangential Flow Filtration Maintenance
Principles of Tangential Flow Filtration Validation and Qualification
References
Recommended Reading
Supercritical Fluid Extraction/Chromatography
Kent M. Payne, Jerry W. King
Theory
Applications of Supercritical Fluids
Supercritical Process Equipments
Conclusion
References
Preparative Separation of Enantiomers, Charles M. Grill, John R. Kern, Scott R. Perrin
Practical Aspects
Optimization Strategy
Preparative Chromatographic Resolution of the ยต-Burke Olefin
Resolution of Racemates by Closed Loop Recycling Chromatography
Continuous Preparative Techniques for Resolving Racemic Mixtures
New Techniques
References
Chromatographic Purification of Recombinant Protein Products, Eugene P. Kroeff
Purification Challenges
System Selectivity
Process Reproducibility
Process Scaleup Considerations
Examples of Chromatographic Purification of rDNA Products
Summary
References
Affinity Chromatography, Wayne P. Olson
Definitions
Origins of Affinity Separations
Affinity Pairs: Examples
Matrices of Choice
Ligand Immobilization Chemistries
Elution Strategies
Analysis of the Products
References
Monoclonal Antibodies, Gary Christiansen
Definitions
Historical Notes
The Production of Monoclonal Antibodies
Purification Objectives and Goals
Purification Methods
Recent Advances and Future Trends
Conclusions
References
Immunoaffinity Purification of Proteins for Injection, and the Issue of Animal Viruses, Wayne P. Olson
Immobilized Antigens and Antibodies - A Research Tool
Immunosorbents for the Purification of Human Clotting Factor VIII for Injection
The Issue of Virus Elimination and/or Destruction
Preferred Methods for Antibody Immobilization
Scaling from the Limiting Step in Process
Charging and Eluting the Column
Issues with Immobilized Antibodies
Automation of the Cycle
Cell Purification with Immobilized Antibodies
Comparison of Immunosorbent with Other Methods
References
Process Validation of Separation Systems, Steven S. Kuwahara, Jane H. Chuan
Types of Validation
Why Validate?
Who, What, and Where to Conduct Validations
Extent of Validations
General Considerations
Getting Started: What Needs to Be in Place Before Beginning Your Validation
Separation Systems
References
A Salute to the Human Plasma Processing Industry and Its Founders, E.J. Cohn et al., Robert Tenold
Fractionation Automation
Centrifuges
Filters and Process Filter Media
Wiped or Thin Film Evaporation Systems
Screen Systems
Ultrafiltration/Diafiltration
Gel Chromatography
Lyophilization
Putting Out Fires
Acknowledgments
References
Index
Biography
Olson\, Wayne P.
