| D&MD’s The Bioprocessing Industry: Increasing Capacity, Production, and Efficiency, 2nd Edition marketing analysis report presents a thorough and organized analysis of this critical industry and its major components. This report covers the most important issues in bioprocessing including the threat of a significant shortage in manufacturing capacity, consolidation in key sectors of the industry and the next drug discovery trends fueling expansion. In addition, more than 50 companies from various elements of the bioprocessing industry are profiled in depth.
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- Chapter 1: Executive Summary
- Chapter 2: Introduction
- The Bioprocessing Industry
- Scope and Objectives of the Bioprocessing Report
- Report Scope
- Report Objectives
- Chapter 3: Types of Biologicals and Their Applications
- Drugs
- Antibiotics
- Hormones
- Cytokines (Cell Growth Factors)
- Enzymes
- Vaccines
- Blood Fractions
- Monoclonal Antibodies
- Diagnostics
- Chapter 4: Regulatory Requirements for Bioprocessing
- Facilities
- Equipment
- Processes
- Chapter 5: Bioprocessing Science and Technologies
- Mass Cell Culture Techniques
- Cells for Culture
- Culture Media
- Culture Equipment
- Bacterial Fermentors
- Animal Cell Suspension Culture
- Anchorage-dependent Cell Culture
- Microcarrier Culture
- Hollow-Fiber Devices
- Transgenic Animals and Plants
- Separation Technology
- Centrifugation
- Cell Disruption
- Filtration
- Purification Technology
- Chromatography
- Ion-Exchange (IEC)
- Hydrophobic Interaction (HIC)
- Biospecific Affinity
- Gel Filtration (GF)
- Reversed Phase Chromatography (RPC)
- Perfusion (PC)
- Typical Protocols
- Purification of Mouse MAb by AC or HIC
- Other Uses of AC
- Expanded Bed and Radial Chromatography
- Filtration
- Submicron Filtration
- Ultrafiltration
- Ultracentrifugation
- Other Technology
- Magnetic Beads
- Electrophoresis
- Virus Inactivation
- Processing the Final Product
- Formulation, Stabilization and Delivery Systems
- Lyophilization
- Analytical Technology
- Chemical Techniques
- Physical Techniques
- Biological Techniques
- Basic Support Utilities
- Water Purification
- Sterilization
- Contamination Control
- Disposables in Bioprocessing
- Disposable Technology and Contract Manufacturing (CMOs)
- Drivers for Single-use Disposable Systems
- Cost Implications
- Disadvantages of Disposable Systems
- Leachables and Extractables
- Elimination of Waste in the Biodisposable Context
- Disposable Bioreactors
- Applications for Disposable Bioreactors
- Disposable Downstream Processing
- Faster Processing
- Cleaning Ease
- Disposable Filters
- Chapter 6: Contract Services in Bioprocessing
- Contract Manufacturers
- References
- Chapter 7: Future Directions of Bioprocessing
- Mass Cell Culture
- Expression Systems
- Bioreactor Design
- Media Improvements
- Transgenics
- Separation
- Purification
- Integrated Processing
- Final Formulation, Stabilization and Lyophilization
- Analysis and Automation
- Chapter 8: Company Profiles
- Abgenix
- Becton Dickinson
- Boehringer Ingelheim
- CSL
- DSM Anti-Infectives
- Dyax
- GE Healtcare
- GTC Biotherapeutics
- Invitrogen
- Large Scale Biology
- Neose Technologies
- PPL Therapeutics
- ProMetic Life Sciences
- Tosoh Corporation
- West Pharmaceutical Services
- TABLE OF EXHIBITS
- Exhibit 2.1 Actual and Projected Sales of Leading Recombinant Products
- Exhibit 2.2 Sales of Products Approved
- Exhibit 2.3 Currently Approved Recombinant Biological Products
- Exhibit 2.4 Annual Sales Reported by Select Bioprocess Suppliers
- Exhibit 2.5 The Major Stages of Bioprocessing
- Exhibit 3.1 FDA-Approved Cytokine Drugs
- Exhibit 3.2 FDA-approved Therapeutic Enzymes
- Exhibit 3.3 Vaccine Types
- Exhibit 3.4 Blood Plasma Fractions
- Exhibit 3.5 Approved Monoclonal Antibodies
- Exhibit 3.6 Current Status Distribution of MABs in Development
- Exhibit 5.1 Flow Chart for a Typical Biopharmaceutical
- Exhibit 5.2 Multi-unit Bench-top Fermentor Set
- Exhibit 5.3 NBS Pilot Fermentor Plant
- Exhibit 5.4 ‘CelliGen’ Production of Protein from Suspended Cells
- Exhibit 5.5 Diagram of the Wave Bioreactor™
- Exhibit 5.6 Automation Partnership “Cellmate” Schematic
- Exhibit 5.7 Diagram of the Rollercell 40
- Exhibit 5.8 Pig Kidney Cells Growing on Cytodex 1
- Exhibit 5.9 Modular System for Spinner Flasks
- Exhibit 5.10 Salk Vaccine Bioreactors at Aventis Pasteur, Canada
- Exhibit 5.11 Applications of SoloHill Microcarriers Bead Types
- Exhibit 5.12 Percell’s Cultisphere Porous Microcarriers
- Exhibit 5.13 CelliGen™ with Fibrous-Bed Basket
- Exhibit 5.14 Centritech® LAB II Unit
- Exhibit 5.15 Cell Culture Expansion by Centritech®
- Exhibit 5.16 Perfusion Production by Centritech™
- Exhibit 5.17 Diagram of Action of BioSep® Sonic Filter
- Exhibit 5.18 Hollow-Fiber Bioreactor
- Exhibit 5.19 IC Flow Circuit
- Exhibit 5.20 Current Status of GTC Transgenic Products
- Exhibit 5.21 Select Transgenic Products of PPL Therapeutics and Pharming Group
- Exhibit 5.22 Cut-away Drawing of Sharples SuperCentrifuge
- Exhibit 5.23 Cut-away View of the ViaFuge™ Pilot
- Exhibit 5.24 Alfa-Laval BTUX 510 Separator
- Exhibit 5.25 Continuous-flow Sonicator Cell
- Exhibit 5.26 Multi-Stack CUNO Zeta-filter
- Exhibit 5.27 Cut-Away Drawing of a Pall Cartridge Filter
- Exhibit 5.28 Suitability of Types of Chromatography to Purification Stages
- Exhibit 5.29 Typical IEC Gradient Elution
- Exhibit 5.30 Typical HIC Gradient Elution
- Exhibit 5.31 Typical Affinity Separation
- Exhibit 5.32 Typical GF Elution
- Exhibit 5.33 Typical RPC Gradient Elution
- Exhibit 5.34 Diffusion-based (a) and Flow-through Chromatography (b)
- Exhibit 5.35 Scale-up on POROS Beads
- Exhibit 5.36 Capture of Mouse IgG on Protein A Column
- Exhibit 5.37 Polishing of Mouse IgG on a GF Column
- Exhibit 5.38 Capture of Mouse IgE on HIC column
- Exhibit 5.39 Polishing of Mouse IgE
- Exhibit 5.40 Purification of GH-receptor Protein on a Toyopearl Affinity Column
- Exhibit 5.41 Expanded Bed Adsorption
- Exhibit 5.42 GE Healthcare Process Comparisons
- Exhibit 5.43 Typical Performance of Millipore Ultrafiltration Membranes
- Exhibit 5.44 Pall DMF Equipment
- Exhibit 5.45 Pall ‘Filtron’ Pilot-scale UF Cassette
- Exhibit 5.46 Millipore Production-scale Unit
- Exhibit 5.47 Sartorius Sartoflow 20 Automatic Closure
- Exhibit 5.48 A/G Technologies UF Process Unit
- Exhibit 5.49 Diagram of Spiral-wound UF Cartridge
- Exhibit 5.50 Rate-zonal Density Gradient Separation in Swinging-tube Rotor
- Exhibit 5.51 Operation of a Beckman JCF-Z Zonal Rotor
- Exhibit 5.52 Separation of Proteins by Magnetic Beads & Biotinylated DNA
- Exhibit 5.53 Suppliers of Paramagnetic Beads
- Exhibit 5.54 Bio-Rad Model 491 Preparative Electrophoresis Cell
- Exhibit 5.55 Diagram of the Gradiflow Electrophoresis Equipment
- Exhibit 5.56 Aseptic Lyophilizer Installation
- Exhibit 5.57 Typical Production Lyophilizer
- Exhibit 5.58 Selected Suppliers of HPLC and GC Equipment and Media
- Exhibit 5.59 Gel Analysis Program for SDS-PAGE Pattern Evaluation
- Exhibit 5.60 Diagram of MS Magnetic Sector Analyzer
- Exhibit 5.61 Effectiveness of Water Purification Methods
- Exhibit 5.62 Clean Room Classes according to FSE 209E
- Exhibit 5.63 New ISO/TC209 Standards
- Exhibit 5.64 Laminar-flow Clean Room
- Exhibit 5.65 Strategic Outlook for Biodisposables
- Exhibit 5.66 Disposable Components and Suppliers for Manufacturing of
- Biologics and Pharmaceuticals
- Exhibit 6.1 Distribution of CMO Services offered by Manufacturing Stage
- Exhibit 6.2 Distribution of CMO Manufacturing Capabilities
- Exhibit 6.3 CMO Directory
- Exhibit 7.1 Continuous-Flow Affinity Chromatography
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