Disposable Bioprocessing Systems

Because of many misconceptions, the biological drug manufacturing industry does not fully utilize disposable components, despite their wide availability. These misconceptions include concerns for the quality of materials, running costs, scalability, the level of automation possible, and the training of staff needed to include these components in existing bioprocessing systems. Not fully realizing the long-term benefits, many manufacturers are unwilling to discard investments made in fixed equipment and traditional stainless steel systems. Regulatory and environmental concerns, however, will eventually compel manufacturers to adopt disposable systems. Making a strong case for disposables, Disposable Bioprocessing Systems demonstrates the true potential of these systems.

Written by a researcher and professor with hands-on experience in designing, establishing, and validating biological manufacturing facilities worldwide, and creating model facilities using maximum disposable technology, this book is the first comprehensive introduction to understanding disposable systems. It gives an overview of the current state of the disposable bioprocessing industry, resolves all controversial issues, and guides readers in choosing disposable components that meet their needs. An important chapter on safety addresses facts and myths about the use of plastics and elastomers—including the issue of leaching—and how to ensure regulatory compliance.

Helping readers understand their choices, the book describes the equipment and systems available to prepare the starting materials for the manufacturing of biological drugs—from disposable containers to filters. The author also discusses costs, regulations, and concerns about waste disposal, and shares his predictions for the future of the disposable bioprocessing industry.

A practical manual for those interested in the transition to disposable systems, this book will also interest students of bioprocessing. It offers a timely view of disposable bioprocessing technology as a "game changer" that will facilitate developing new drugs and conducting research in the emerging field of stem cells and gene therapy.

Sarfaraz K. Niazi has been teaching pharmaceutical sciences and conducting research in the field of drug and dosage form development for over 35 years. A former professor at the University of Illinois, Dr. Niazi has written over a hundred papers, dozens of books, and owns dozens of patents for his inventions in the field of drug development and biopharmaceutical processing, including patents on novel bioreactors. His first book on the subject, Handbook of Biogeneric Therapeutic Proteins (CRC Press), was widely received as a primer in the field of biological manufacturing. Niazi has hands-on experience in designing, establishing, and validating biological manufacturing facilities worldwide. He lives in Deerfield, Illinois.

The Bioprocessing Industry—An IntroductionSummaryAppendix I: Complete Lines of Disposable SystemsMillipore Offers an Extensive Line (www.millipore.com)Chromatography Columns Safety of Disposable SystemsPolymers and AdditivesPartnering with VendorsResponsibility of SponsorsRegulatory RequirementsRisk AssessmentBackground International Guidance and Standards ContainersProprietary Bag SuppliersGeneric Bag SuppliersTank Liners2D Fluid Containers2D Powder Bags3D BagsTransportation ContainerSummaryMixing SystemsTypes of MixingStirring Magnetic MixerStirring Mechanical Coupling Mixer Tumbling MixerOscillating MixerPeristaltic Mixer SummaryDisposable Bioreactors Xcellerex BioreactorCellexus BioreactorCELL-tainer Cell Culture SystemWave-Mixed BioreactorsStirred Single-Use BioreactorsIntegrity™ PadReactor™CellReady BioreactorThe Game Changers in Disposable Bioreactor Industry Connectors and TransfersTubingFittings and AccessoriesPumpsAseptic CouplingAseptic ConnectorsWeldingAseptic Transfer Systems Tube SealersSamplingConclusion Controls Sampling Systems TRACE SystemOptical Sensors Biomass SensorsElectrochemical SensorsPressure SensorsConclusions Downstream ProcessingThe Case of Monoclonal Antibodies: A GE ReportMembrane Chromatography Virus Removal BuffersFluid Management BioseparationDepth FiltrationUltrafiltration Integrated Systems Filling and Finishing SystemsRobert Bosch Packaging SystemsPDC Aseptic Filling SystemsSummaryFiltrationDead-End FiltrationCross-Flow FiltrationFiltration MediaPolymer Membranes Microfiltration Cross-FlowConclusionRegulatory ComplianceRegulatory BarriersIrradiation and Sterilization ValidationEnvironmental ConcernsBiosafetyLiquid WasteIncinerationPyrolysisGrind and AutoclaveLandfillTreatmentOverall Environmental ImpactSummaryAppendix B: Classification of Human Etiologic Agents on the Basis of HazardAppendix K: Physical Containment For Large-Scale Uses of Organisms Containing Recombinant DNA MoleculesEpilogue Large ScaleIntegrityFlexibilityUniversal UseScale-UpCostOut of SteamValidationLeachablesAnimal OriginsThe Stainless ChallengeStandardizationUpstreamComplianceHigh-Expression Cell LinesFlexible FactoriesSmall CompaniesUnitary SystemsBiosafetyAutoclavesSIP/CIPDistilled Water LoopsLow Ceiling HeightsModular SystemsGentle Mixing2D BagsFluoropolymer BagsProtein CaptureDownstream ProcessingClosed SystemsMolecule-Specific FacilitiesMax-Dispo ConceptLeachables/ExtractablesMultipurpose Disposable BioreactorsBibliographyIndex