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The Bioprocessing Industry: Increasing Capacity, Production, and Efficiency (2nd Edition)

Published by: Drug and Market Development Publishing

Published: Aug. 1, 2006 - 266 Pages


Table of Contents


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

Abstract

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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