Separations Technology Pharmaceutical and Biotechnology Applications

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. OlsonPure Drugs v. Crude Preparations: Conventional Pharmaceuticals v. Folk MedicineDeveloping a Drug (Apart from Regulatory Issues)Sizing a Chromatographic SystemPurification MethodsPurification Steps and YieldIsolatorsScaleup from a Published Bench MethodAutomationReferencesMembrane Pervaporation, Timothy deVilliers NaylorPrinciples of PervaporationFactors Affecting Membrane PerformanceEnergy RequirementsApplication OpportunitiesConclusionsReferencesTangential Flow Filtration, Stephen L. Michaels, et al.The History of Tangential Flow FiltrationPrinciples and TheoryTangential Flow Filtration EquipmentApplication Classes in Pharmaceutical SeparationsPrinciples of Tangential Flow Filtration MaintenancePrinciples of Tangential Flow Filtration Validation and QualificationReferencesRecommended ReadingSupercritical Fluid Extraction/ChromatographyKent M. Payne, Jerry W. KingTheoryApplications of Supercritical FluidsSupercritical Process EquipmentsConclusionReferencesPreparative Separation of Enantiomers, Charles M. Grill, John R. Kern, Scott R. PerrinPractical AspectsOptimization StrategyPreparative Chromatographic Resolution of the µ-Burke OlefinResolution of Racemates by Closed Loop Recycling ChromatographyContinuous Preparative Techniques for Resolving Racemic MixturesNew TechniquesReferencesChromatographic Purification of Recombinant Protein Products, Eugene P. KroeffPurification ChallengesSystem SelectivityProcess ReproducibilityProcess Scaleup ConsiderationsExamples of Chromatographic Purification of rDNA ProductsSummaryReferencesAffinity Chromatography, Wayne P. OlsonDefinitionsOrigins of Affinity SeparationsAffinity Pairs: ExamplesMatrices of ChoiceLigand Immobilization ChemistriesElution StrategiesAnalysis of the ProductsReferencesMonoclonal Antibodies, Gary ChristiansenDefinitionsHistorical NotesThe Production of Monoclonal AntibodiesPurification Objectives and GoalsPurification MethodsRecent Advances and Future TrendsConclusionsReferencesImmunoaffinity Purification of Proteins for Injection, and the Issue of Animal Viruses, Wayne P. OlsonImmobilized Antigens and Antibodies - A Research ToolImmunosorbents for the Purification of Human Clotting Factor VIII for InjectionThe Issue of Virus Elimination and/or DestructionPreferred Methods for Antibody ImmobilizationScaling from the Limiting Step in ProcessCharging and Eluting the ColumnIssues with Immobilized AntibodiesAutomation of the CycleCell Purification with Immobilized AntibodiesComparison of Immunosorbent with Other MethodsReferencesProcess Validation of Separation Systems, Steven S. Kuwahara, Jane H. ChuanTypes of ValidationWhy Validate?Who, What, and Where to Conduct ValidationsExtent of ValidationsGeneral ConsiderationsGetting Started: What Needs to Be in Place Before Beginning Your ValidationSeparation SystemsReferencesA Salute to the Human Plasma Processing Industry and Its Founders, E.J. Cohn et al., Robert TenoldFractionation AutomationCentrifugesFilters and Process Filter MediaWiped or Thin Film Evaporation SystemsScreen SystemsUltrafiltration/DiafiltrationGel ChromatographyLyophilizationPutting Out FiresAcknowledgmentsReferencesIndex

Olson\, Wayne P.