Table of Contents
Chapter 1: Executive Summary
Chapter 2: Economics of Biodisposables: Efficient, Fast and Flexible Product
Development
- Disposable Technology and Contract Manufacturing (CMOs)
- Drivers for Single-Use Disposable Systems
- Disposable Bag Technology-Pacific GMP, AppTec, Stedim
- Market Implementation
- Industrial Advantages of Disposable Components
- Disadvantages of Disposable Systems
- Leachables and Extractables
- Elimination of Waste in the Biodisposable Context
- Return of Investment (ROI) Options
- A 100 - 1000L Pilot Facility Costs $10 - 50 million
- Contract Manufacturer Xcellerex Case Study - Advantages of Biodisposables
- Process Comparison Models
- Model Estimation of Simulations
- Monoclonal Antibody Production
- Disposables Reduce Overall Cost of Manufacture
- Conversion from Stainless Steel Equipment to Disposable Filtration
- Disposable Filters-For Use in Chromatography
- Summary
Chapter 3: Disposable Bioreactors
- Scaling Up Logistics
- Comparison and Validation of Disposable Bioreactor Systems
- Growing Cells in Bags-Wave CellbagsR Characteristics
- Factors that Amplify the Bioreactor's Yield
- Wave Biotech Bioreactor Case Histories
- CatchMab's Tsunami Bioreactor
- Osmotek's LifeReactor
- Cellexus Biosystems
- Disposable Bioreactor Flasks, Bottles, and Other Containers
- Integra Biosciences' CELLine Biodisposable Flask
- FiberCell System's FiberCell Hollow Fiber Bioreactor
- Hollow Fiber Bioreactor Applications:
- Synthecon's Rotary Cell Culture System
- Fluorometrix's Cellstation
- Cellon's RollerCell
- Integra Biosciences' Cellroll
- Corning's CellCubeR
- Multi Laminate Plastic Bags
Chapter 4: Downstream Processing and Separation Sciences
- Disposable Downstream Processing
- Faster Processing
- Cleaning Ease
- Disposable Filters
- Disposable Mixing, Filling and Sampling-HyNetic, Alfa Laval Biokinetic,
Millipore, LevTech, Acerta, Nova Aseptic
- Sartorius
- LevTech
- Millipore
- NovAseptic
- Sampling Systems
- Disposable Sampling Pump
- Sterile Connectors and Clean Room Technology
- Steam-in-place (SIP) Connector
- Fully Assembled, Pre-sterilized Filtration Systems
- Millipore's Mobius Disposable Systems
- Separation Sciences: Filtration and Chromatography
- Disposable Filter Systems
- Disposable Filtration Market Statistics
- Filtration Technology
- Enhancing the Efficiency of Disposable Filters
- Sterile Filtration-Sartorius, Millipore, Pall Corp
- Millipore Sterile Filtration
- Sartorius
- Disposable Filter Capsules and Chromatography Columns
- Membrane Adsorption Chromatography
- Membrane Chromatography and Viral Clearance
- Affinity Chromatography and Antibody Purification
- Inline Filters for Disposable Bioreactors
- Recovery of Cell Products through Chromatography
- Cross/Tangential Flow Filters in Cell Processing and Diafiltration
- Cross Flow Filtration
- Sartorius BBI Systems Inc
- CellFlo Applications
- Cross Flow Process Modes for Cell Processing
- Tangential Flow Filtration TFF from SciLogic
- Blood and Serum Fractionation
- Blood Fractionation
- Serum Fractionation
- Biosep Accoustic Technology-Applikon
Chapter 5: Biodisposables-Facility Design and Future Developments
- Facility Design Capabilities with Disposables
- Multi-Component Systems
- Flexel 3D Mixing System with Temperature Control
- The Single-Use Rapid Aseptic Fluid Transfer (RAFT) System
- Kleenpak Single-Use Aseptic Connectors
- Celsius-Pak
- Functional and Environmental Constraints
- Optimizing Facility Design
- Suppliers
- Biocompatibility
- Production Volume
- Disposal
- Disposable Design Optimization
- Regulatory Considerations for Disposable Component Validation
- Sample Regulatory Requirements
- Future Outlook of Disposables
- Disposable Product Innovations
- Market Projections
- Bags, Bioreactors, Filters, etc
- Disposable Biosensors
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