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Upstream Processing in Biopharmaceuticals - Increasing use of Low-Cost Disposable Bioreactors to Drive the Upstream Bioprocessing Market

Published By :

GBI Research

Published Date : Mar 2011

Category :

Manufacturing, Packaging & Detailing

No. of Pages : 109 Pages


GBI Research\'s report, Upstream Processing in Biopharmaceuticals - Increasing Use of Low-Cost Disposable Bioreactors to Drive the Upstream Bioprocessing Market, provides the key to market data on overall upstream process, Contract Manufacturing Organization (CMO) market for upstream processing, and the cell culture and reagent market. Market. 

The report also analyzes the strengths, weaknesses, opportunities, and threats for the key players in the CMO and cell culture and regent market. The report also discusses the key market drivers and restraints for the upstream processing, outsourcing to CMO and cell culture and reagent market. The report is based on proprietary databases, primary and secondary research and in-house analysis by GBI Researchs team of industry experts to provide a comprehensive view of the upstream processing in biopharmaceuticals.

Scope

The scope of this report includes - 

  • Key emerging technologies in upstream processing for the manufacturers of Biopharmaceuticals in the pharmaceuticals industry
  • Market revenues and forecasts for upstream Processing of Biopharmaceuticals in the CMO market from 2009 to 2016.
  • Key drivers, restraints challenges and trends in upstream processing.
  • Technology landscape along with their application in upstream bioprocess that shape the bio manufacturing industry
  • Analysis of competitive assessment of key CMO and cell culture and reagent players.

Reasons to buy

The report will enhance your decision making capability. It will allow you to - 

  • Formulate strategies to increase your companys growth by understanding the new growth opportunities, market size and growth prospectus in the upstream market.
  • Work around the technology hurdles by identifying the key trends shaping and driving the market for upstream process.
  • Differentiate yourself from competitors and develop new solutions for the bio pharmaceutical manufacturing industry by understanding the existing competitive landscape and how it is evolving to meet the increasing demands.
  • Draft efficient strategies by understanding best practices, identifying key players in the CMO market and cell culture and regent market.
Table of Contents

1 Table of Contents

1 Table of Contents 3
1.1 List of Tables 7
1.2 List of Figures 8

2 Upstream Processing in Biopharmaceuticals Introduction 10

2.1 GBI Research Report Guidance 10

3 Upstream Processing in Biopharmaceuticals -Biopharmaceuticals Overview 11
3.1 Important Classes of Biopharmaceuticals 11
3.1.1 Monoclonal Antibodies (mAb) 12
3.1.2 Vaccines 12
3.1.3 Hormones 12
3.1.4 Enzymes 12
3.1.5 Interferon 12
3.1.6 Clotting Factors 12
3.1.7 Therapeutic Protein 13
3.2 Biopharmaceutical Manufacturing Process Overview 14
3.2.1 Overview of Microbial Fermentation 15
3.2.2 Overview of Mammalian Cell Culture Systems 15
3.2.3 Cell Banking and Seed Culture 15
3.2.4 Overview of Upstream Process 16
3.2.5 Harvest 17
3.2.6 Downstream Process (DSP) 17
3.2.7 Formulation 19
3.2.8 Comparison of Upstream Processing and Downstream Processing 19

4 Upstream Processing in Biopharmaceuticals Upstream Process In Detail 20
4.1 Introduction 20
4.2 Bioreactors and Cells 21
4.3 In Process Control 23
4.3.1 pH 23
4.3.2 Temperature 24
4.3.3 Holding and Storage Time 24
4.3.4 Shear Forces 24
4.3.5 Key Points to be remembered while starting Up Upstream Processes 24
4.3.6 Major Issues during Upstream Processing 25
4.4 Scale Up 25
4.4.1 The Upstream Output can be increased 26
4.4.2 Upstream Bioprocessing 28
4.4.3 Some Key Points While Starting Up Upstream Processes 28
4.4.4 Emerging Production Systems in Upstream Bioprocess 29
4.4.5 Conclusion 29

5 Upstream Processing in Biopharmaceuticals Market Characterization 30
5.1 Culture Media Overview 30
5.1.1 Cell Culture 30
5.2 Key Biologic Reagents 31
5.2.1 Amino Acids 31
5.2.2 Growth Factors 31
5.2.3 Albumin 31
5.2.4 Transferrin 31
5.3 Culture Media/Reagent Suppliers 32
5.4 Culture Media/Reagent Market Size 33
5.4.1 Market Drivers 34
5.4.2 Market Restraints 35
5.5 Bioreactor 35
5.5.1 Selection of Bioreactors 35
5.5.2 Batch Bioreactor 36
5.5.3 Continuous Bioreactor 37
5.5.4 Submerged Bioreactors Stirred Tank 38
5.5.5 Airlift Bioreactor 38
5.6 Upstream Process and CMO 39
5.6.1 Why CMO? 39
5.6.2 Build Vs. Buy Decision 39
5.6.3 Selection of CMOs 41
5.6.4 CMO- Upstream Market Size 43
5.6.5 Drivers for Outsourcing 44
5.6.6 Restraints to Outsourcing 48
5.7 Upstream Process Market Size 49
5.8 Upstream Process Trends 50
5.8.1 Inclination towards the Transgenic Plant/ Animals 50
5.8.2 R&D and Technology Based Advancements in Upstream Process 52
5.8.3 Focus on Single Use Technology 52
5.9 Upstream Process Drivers 53
5.9.1 Advances in Media and Cell-Line Development will Improve Overall Upstream Process Market 53
5.9.2 Innovations in Transgenic Production Systems will Drive Upstream Process Market in Future 54
5.9.3 Emergence of Newer Technologies Will Improve the Upstream Processing 54
5.10 Upstream Process Restraints 54
5.10.1 R&D Focus has Shifted to Downstream Process 54
5.10.2 High Cost and Time Spent in Upstream Process Affecting Productivity 54

6 Upstream Processing in Biopharmaceuticals Competitive Landscape 55
6.1 Key Players in the Culture Media and Reagents Market 55
6.1.1 Life Technologies 55
6.1.2 Sigma Aldrich Corporation 57
6.1.3 Millipore Corporation (a Merck KGaA company) 59
6.1.4 Thermo Fisher Scientific 61
6.2 Key CMO Players 63
6.2.1 Lonza Group Ltd (Lonza) 63
6.2.2 Boehringer Ingelheim GmbH (Boehringer) 65
6.2.3 Avecia Biotechnology 67
6.2.4 Diosynth Biotechnology 69
6.2.5 Sandoz GmbH (Sandoz) 71

7 Upstream Processing in Biopharmaceuticals Technology Landscape 73
7.1 Transgenic Animals (A Live Bioreactor) 73
7.1.1 Transgenic Chickens 74
7.1.2 Proteins from Herd 74
7.2 Transgenic Plants 75
7.2.1 Innovative Technologies 76
7.2.2 Challenges 78
7.2.3 Cell Culture 80
7.3 Single Use Disposable Bioreactors 83
7.3.2 Some Recent Products Developed by Major Firms 84
7.3.3 Challenges 85
7.4 Use of Information Technology to Increase Productivity 86

8 Upstream Processing in Biopharmaceuticals Guidelines, Regulatory Landscape 88
8.1 Quality by Design (QbD) 88
8.2 Process Analytical Technology (PAT) 90
8.2.1 Importance of PAT 91
8.2.2 Factors Limiting Implementation of PAT 91
8.2.3 A summary of PAT benefits is as follows: 91
8.3 ICH Guidelines 92
8.3.1 Q5A (R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 92
8.3.2 Q5B: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products 92
8.3.3 Q5C: Quality of Biotechnological Products Stability Testing of Biological Products 93
8.3.4 Q5D: Derivation and Characterizations of Cell Substrates Used for Production of Biotechnological/Biological Products 93
8.3.5 Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process 94
8.4 The US Regulatory Landscape 94
8.4.1 PHS Act 94
8.5 Europe Regulatory Landscape 95
8.5.1 EMEA Guidelines 95
8.5.2 Key Changes in EMEA Guidelines 98
8.5.3 Types of Guidelines within the Biologics Legislative 98
8.6 Japan 98
8.6.1 Health Policy Bureau 98
8.6.2 Office 1 99
8.6.3 Office 2 99
8.6.4 Review and Guidelines 99

9 Upstream Processing in Biopharmaceuticals Strategic Consolidations 100
9.1 Reasons for Strategic Consolidations in Biologics Manufacturing 100
9.1.1 Uninterrupted Supply to Meet the Demand 100
9.1.2 Overall Cost Reduction 100
9.1.3 Global Expansion to Stay Ahead in Competition 100
9.1.4 High Regulation Requirement 100
9.1.5 Acquiring Technical Expertise 100
9.1.6 Time Pressure and Synergy Innovation 101
9.2 Potential Problems in Strategic Consolidations 101
9.2.1 Incorrect Valuation 101
9.2.2 Capital Problem 101
9.2.3 Compliance Difficulty 101
9.3 Important Alliances in Biologics Manufacturing 101
9.3.1 Lonza in an Agreement with Odyssey Thera, Inc. 101
9.3.2 DSM Biologics (DSM) and Crucell NV Enter into an Agreement with Bioceros BV 101
9.3.3 Cobra Biomanufacturing Plc (Cobra) 102
9.3.4 Angel Biotechnology Holdings Plc 102
9.3.5 DSM Biologics Has Entered into an Agreement with Australian Governments to Build and Operate a Biopharmaceutical Manufacturing Facility in Brisbane 102
9.3.6 Lonza Enter into Licensing Agreement with Crucell 102
9.3.7 Gamida Cell Enters into Licensing Agreement with Amgen 102
9.3.8 Life Technologies Enters into Licensing Agreement with Indian Immunological 103
9.4 Recent M&A Deals in Biologics Manufacturing 103
9.4.1 Genmab Acquiring Manufacturing Facility Currently Owned By PDL Biopharma 103
9.4.2 BAYER Schering Pharma AG, Germany acquires a biologics manufacturing facility in from Novartis 103
9.4.3 Lonza Completed the Acquisition of Amaxa 103
9.4.4 Lonza Group Completed the Acquisition of Cambrexs Research Bioproducts 103
9.4.5 Oso Biopharmaceuticals Manufacturing, LLC completed the acquisition of Catalent\'s Albuquerque 103
9.4.6 Sanofi Pasteur Acquires M

List of Table


Table 1: Upstream Processing in Biopharmaceuticals, Comparison of Upstream and Downstream Process 19
Table 2: Upstream Processing in Biopharmaceuticals, Technology Differences between Perfusion and Fed-Batch 22
Table 3: Upstream Processing in Biopharmaceuticals, Clean Room Classification and Specification 23
Table 4: Upstream Processing in Biopharmaceuticals, Various Manufacturing Models 26
Table 5: Upstream Processing in Biopharmaceuticals, Comparison of Therapeutic Protein Production from Different System 26
Table 6: Upstream Processing in Biopharmaceuticals, Examples and Applications of Specialty Media 31
Table 7: Upstream Processing in Biopharmaceuticals, Culture Media/Reagent Suppliers 32
Table 8: Upstream Processing in Biopharmaceuticals, Culture Media and Reagent Market Forecast,($bn), 2009-2016 33
Table 9: Upstream Processing in Biopharmaceuticals, Reason for Biotechnology Companies to Self Manufacture and/or Outsource 40
Table 10: Upstream Processing in Biopharmaceuticals, CMO Upstream Market Forecast,($bn),2009-2016 43
Table 11: Upstream Processing in Biopharmaceuticals, Approximate Time and Cost for Establishment of Manufacturing Capacity 47
Table 12: Upstream Processing in Biopharmaceuticals, Upstream Market Forecast,($bn),2009-2016 49
Table 13: Upstream Processing in Biopharmaceuticals, List of Therapeutic Proteins Produced in Milk of Transgenic Animals 73
Table 14: Upstream Processing in Biopharmaceuticals, Plants Used for Biopharmaceutical Production 75
Table 15: Upstream Processing in Biopharmaceuticals, Plant-Derived Biopharmaceuticals that are in the Pipeline for Commercialization 77
Table 16: Upstream Processing in Biopharmaceuticals, Types of Single Use Bioreactors and Vendors 83
Table 17: Upstream Processing in Biopharmaceuticals, Effect of Culture Conditions on Glycosylation 86
Table 18: Upstream Processing in Biopharmaceuticals, Biologics Manufacturing, Regulatory Landscape, Comparison, 2010 92

List of Chart


Figure 1: Upstream Processing in Biopharmaceuticals, Types of Biopharmaceutical Products 11
Figure 2: Upstream Processing in Biopharmaceuticals, Schematic Flow Diagram of a Typical Biomanufacturing Process 14
Figure 3: Upstream Processing in Biopharmaceuticals, Cell Bank System 15
Figure 4: Upstream Processing in Biopharmaceuticals, Overview of the General Drug Development Process 17
Figure 5: Upstream Processing in Biopharmaceuticals, Technologies Employed along with Steps 18
Figure 6: Upstream Processing in Biopharmaceuticals, Outline of the Upstream Process 20
Figure 7: Upstream Processing in Biopharmaceuticals, Types of Upstream Process 21
Figure 8: Upstream Processing in Biopharmaceuticals, Effect of Titer Volume on Productivity 27
Figure 9: Upstream Processing in Biopharmaceuticals, Culture Media and Regent Market Forecast,($bn), 2009-2016 33
Figure 10: Upstream Processing in Biopharmaceuticals, Culture Media and Reagent Market Growth Drivers and Restraint 34
Figure 11: Upstream Processing in Biopharmaceuticals, Tray Bioreactor 36
Figure 12: Upstream Processing in Biopharmaceuticals, Stirred Tank Bioreactor 37
Figure 13:Upstream Processing in Biopharmaceuticals, Strategies, Key Check Points, CMOs 41
Figure 14: Upstream Processing in Biopharmaceuticals, CMO Upstream Market Forecast,($bn),2009-2016 43
Figure 15: Upstream Processing in Biopharmaceuticals, Drivers and Restraints for CMO Outsourcing 44
Figure 16: Upstream Processing in Biopharmaceuticals, CMO Fragmentation According to Process Technique 45
Figure 17: Upstream Processing in Biopharmaceuticals, CMO Fragmentation According to the Cell Culture Capacity 46
Figure 18: CMO Fragmentation According to Capacity (Microbiological Culture) 46
Figure 19: Upstream Processing in Biopharmaceuticals, Upstream Process Market Forecast, ($bn), 2009-2016 49
Figure 20: Upstream Processing in Biopharmaceuticals, Trends in Upstream Processing, 2010 50
Figure 21: Upstream Processing in Biopharmaceuticals, Comparison of Requirement for Production of MAb (100 Kg scale), 2010 51
Figure 22: Upstream Processing in Biopharmaceuticals, Drivers and Restraints 53
Figure 23: Upstream Processing in Biopharmaceuticals, Life Technologies Business Overview, 2010 55
Figure 24: Upstream Processing in Biopharmaceuticals, Life Technologies SWOT Analysis 56
Figure 25: Upstream Processing in Biopharmaceuticals, Sigma-Aldrich Business Overview, 2010 57
Figure 26: Upstream Processing in Biopharmaceuticals, Sigma-Aldrich SWOT Analysis 58
Figure 27: Upstream Processing in Biopharmaceuticals, Millipore Corp., Business Overview 59
Figure 28: Upstream Processing in Biopharmaceuticals, Millipore Corp SWOT Analysis 60
Figure 29: Upstream Processing in Biopharmaceuticals, Thermo Fisher Scientific Inc., Business Overview, 2010 61
Figure 30: Upstream Processing in Biopharmaceuticals, Thermo Fisher Scientific SWOT Analysis 62
Figure 31: Upstream Processing in Biopharmaceuticals, Lonza Business Overview 63
Figure 32: Upstream Processing in Biopharmaceuticals, Lonza SWOT Analysis 64
Figure 33: Upstream Processing in Biopharmaceuticals, Boehringer Ingelheim, Business Overview, 2010 65
Figure 34: Upstream Processing in Biopharmaceuticals, Boehringer Ingelheim, SWOT Analysis 66
Figure 35: Upstream Processing in Biopharmaceuticals, Avecia Biotechnology Business Overview, 2010 67
Figure 36: Upstream Processing in Biopharmaceuticals, Avecia Biotechnology, SWOT Analysis 68
Figure 37: Upstream Processing in Biopharmaceuticals, Diosynth Biotechnology, Business Overview, 2010 69
Figure 38: Upstream Processing in Biopharmaceuticals, Diosynth Biotechnology, SWOT Analysis 70
Figure 39: Upstream Processing in Biopharmaceuticals, Sandoz GmbH, Business Overview, 2010 71
Figure 40: Upstream Processing in Biopharmaceuticals, Sandoz GmbH, SWOT Analysis 72
Figure 41: Upstream Processing in Biopharmaceuticals, Advantages and Disadvantages of Transgenic Plants 75
Figure 42: Upstream Processing in Biopharmaceuticals, Key features of Lemna 76
Figure 43: Upstream Processing in Biopharmaceuticals, Transgenic Plants Challenges 78
Figure 44: Upstream Processing in Biopharmaceuticals, Snapshot for BI HEX 80
Figure 45: Upstream Processing in Biopharmaceuticals, Challenges with Single Use Disposable Bioreactor 85
Figure 46: Upstream Processing in Biopharmaceuticals, Europe, Guidelines, 2010 95
Figure 47: Upstream Processing in Biopharmaceuticals, Regulatory Landscape, Japan, Process, 2010 99
Figure 48:Upstream Processing in Biopharmaceuticals, Strategic Consolidations in Biologics Manufacturing 100

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