Separations Technology: Pharmaceutical and Biotechnology Applications - Wayne P. Olson

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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 -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