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Manufacturing of Vaccines - Cell Culture Technology Gradually Replacing Egg-Based Manufacturing
Date:9/6/2011

NEW YORK, Sept. 6, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Manufacturing of Vaccines - Cell Culture Technology Gradually Replacing Egg-Based Manufacturing

http://www.reportlinker.com/p0610894/Manufacturing-of-Vaccines---Cell-Culture-Technology-Gradually-Replacing-Egg-Based-Manufacturing.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

Manufacturing of Vaccines - Cell Culture Technology Gradually Replacing Egg-Based Manufacturing

Summary

GBI Research, the leading business intelligence provider, has released its latest research report, "Manufacturing of Vaccines - Cell Culture Technology Gradually Replacing Egg-Based Manufacturing", which provides insights into the production methods of vaccines and into vaccine production capacity. The report discusses the egg-based and cell culture-based vaccine manufacturing processes in depth. Furthermore, details of the whole process throughput and the technologies used in vaccine manufacturing are provided in the report. It also offers a clear view of the regulatory landscapes of the US, Europe and Japan. It includes profiles of the key players and the alliances which exist in the world of vaccine manufacturing. The report explores the emerging technologies, drivers and barriers of the vaccine manufacturing process and the challenges and unmet needs present in the market.

GBI Research analysis suggests that Singapore and China are emerging as the biggest hot spots for the future of vaccine manufacturing, along with India. The vaccine manufacturing market of Singapore is growing at a rate of around 20%. Furthermore, regulatory support from the governments of these three countries is high. The in depth analysis of the report is based on propriety databases, primary and secondary research and in house analysis by the GBI Research team of experts.

GBI Research analysis also gives details of the stakeholders in the vaccine manufacturing industry and their importance within the industry. The major vaccine manufacturers are focused on acquiring new technologies and strengthening their presence in the market, by collaborating with or acquiring small and medium sized biotech companies that have strong vaccine candidates in their pipeline. R&D activities also indicate the development of new technologies and novel vaccines that can revolutionize the market in the near future.

Scope

The report analyses vaccine manufacturing processes, market characterization, the regulatory landscape and the current scenario of the vaccine manufacturing industry. The report covers the following -

- Data and analysis of the global vaccine production capacity as of 2010.

- Key drivers and restraints related to the growth of the vaccine manufacturing process.

- The Regulatory landscape of the US, Europe and Japan, including the overview of the regulatory authorities in these countries.

- The Competitive landscape of the vaccine market, including profiles of the top companies. The companies studied in the report are GlaxoSmithKline, Sanofi Pasteur, Merck, Novartis, Pfizer and CSL Ltd.

- Important strategies in vaccine manufacturing, including manufacturing and outsourcing strategies.

Reasons to buy

The report will help business development and marketing executives strategize their product launches by doing the following -

- Build effective strategies by identifying the potential hotspots for vaccine manufacturing.

- Develop key strategic initiatives by studying the portfolios of the top players.

- Develop vaccine manufacturing expansion strategies by identifying drivers and restraints.

- Reinforce market entry and market expansion strategies in the US, Europe and Japan, by exploiting strong growth opportunities.

- Formulate strategies to increase your company's growth and develop new solutions for the vaccine manufacturing industry by understanding the current competitive scenario, as well as the challenges and unmet needs facing the vaccine industry.

1 Table of Contents

1 Table of Contents 3

1.1 List of Tables 5

1.2 List of Figures 6

2 Manufacturing of Vaccines - Introduction 7

2.1 GBI Research Report Guidance 7

3 Manufacturing of Vaccines - Overview of Manufacturing 8

3.1 Upstream Bioprocessing 8

3.2 Downstream Bioprocessing 8

3.3 Methods for Producing Vaccines 8

3.3.1 Live Whole Virus Vaccines 9

3.3.2 Inactivated Whole Virus Vaccines 9

3.3.3 Subunit Vaccines 9

3.3.4 Recombinant Virus Vaccines 9

3.3.5 Egg-Based Vaccines 9

3.3.6 DNA Vaccines 9

3.4 Current Scenario of the Vaccine Manufacturing Industry 9

4 Manufacturing of Vaccines - Role of Manufacturing in the Vaccine Industry 10

4.1 Comparison of Manufacturing of Vaccines with Manufacturing of Biologics 10

4.2 Stakeholders for Manufacturing within the Company 11

4.2.1 R&D Division 11

4.2.2 Marketing Division 12

4.2.3 Sales Division 12

4.2.4 Manufacturing Division 14

4.3 Stakeholders for Manufacturing within the Industry 15

4.3.1 Raw Material Suppliers 15

4.3.2 Packaging Suppliers 16

4.3.3 Distributors 17

5 Manufacturing of Vaccines - Vaccine Manufacturing Process 19

5.1 Overview 19

5.1.1 Inactivated Influenza Vaccines 19

5.1.2 Live Attenuated Influenza Vaccines 19

5.1.3 Pandemic Influenza Vaccines 19

5.2 Raw Materials 20

5.2.1 Process Design 20

5.2.2 Key Positions 20

5.2.3 Supporting Technology 21

5.3 Assembly 21

5.3.1 Inactivated Influenza Vaccine; Egg-Based Manufacture 21

5.3.2 Inactivated Influenza Vaccine; Cell Culture-Based Manufacture 23

5.3.3 Live Attenuated Influenza Vaccines; Egg-Based Manufacture 24

5.3.4 Live Attenuated Influenza Vaccines; Cell-Culture Based Manufacture 25

5.3.5 Parvovirus B19 VLP Vaccine 25

5.3.6 Process Design 26

5.3.7 Process Throughput 31

5.3.8 Key Positions 32

5.3.9 Supporting Technology 33

5.4 Inventory 35

5.4.1 Process Design 35

5.4.2 Process Throughput 37

5.4.3 Key Positions 37

5.5 Distribution 38

5.5.1 Process Design 38

5.6 Challenges Faced in Vaccine Manufacturing 38

5.6.1 Technological Expertise 38

5.6.2 Initial Capital Investment 39

5.6.3 Regulatory Challenges 39

5.7 Unmet Needs in Vaccine Manufacturing 40

5.7.1 High Yield Maintenance 40

5.7.2 Cost 41

5.7.3 Time 42

5.7.4 Regulation 44

6 Manufacturing of Vaccines - Vaccine Manufacturing Industry 45

6.1 Market Characterization of Vaccine Manufacturing Industry 45

6.1.1 Overview 45

6.1.2 Vaccine Production Capacity 46

6.1.3 Contract Vaccine Manufacturing Market 47

6.1.4 Demand vs Production 48

6.1.5 Drivers for Growth of Vaccine Manufacturing 48

6.1.6 Barriers for Growth of Vaccine Manufacturing 50

6.2 Competitive Assessment 51

6.2.1 Market Share 51

6.2.2 Profiles of Key Players 51

6.3 Emerging Technologies 57

6.3.1 Upstream Bioprocessing 57

6.3.2 Downstream Bioprocessing 57

6.4 Alliances for Vaccine Manufacturing 59

6.4.1 Vaccine Facility Construction Alliance 59

6.4.2 Contract Manufacturing Alliances 59

6.5 Strategies in Vaccine Manufacturing 60

6.5.1 Manufacturing Strategies 60

6.5.2 Outsourcing Strategies 62

7 Manufacturing of Vaccines - Regulatory Landscape 64

7.1 The US 64

7.2 Europe 66

7.3 Japan 67

8 Manufacturing of Vaccines - Emerging Vaccine Manufacturing Hotspots 68

8.1 Singapore 68

8.1.1 Regulations 68

8.1.2 Key Drivers and Restraints 68

8.1.3 Drivers 69

8.1.4 Restraints 69

8.2 China 70

8.2.1 Regulations 70

8.2.2 Key Drivers and Restraints 71

8.2.3 Drivers 72

8.2.4 Restraints 72

8.3 India 74

8.3.1 Regulations 74

8.3.2 Drivers 75

8.3.3 Restraints 75

9 Manufacturing of Vaccines- Appendix 77

9.1 Market Definitions 77

9.2 Abbreviations 77

9.3 Research Methodology 77

9.3.1 Role of Manufacturing in the Vaccine Industry 78

9.3.2 The Vaccine Manufacturing Process 78

9.3.3 Vaccine Manufacturing Industry 78

9.3.4 Regulatory Landscape 78

9.4 Contact Us 78

9.5 Disclaimer 79

9.6 Sources 79

1.1 List of Tables

Table 1: Manufacturing of Vaccines, Comparison of Manufacturing of Vaccines with Manufacturing of Biologics 10

Table 2: Manufacturing of Vaccines, Raw Material Suppliers 15

Table 3: Manufacturing of Vaccines, Major Packaging Suppliers 17

Table 4: Manufacturing of Vaccines, Major Vaccine Distributors 18

Table 5: Manufacturing of Vaccines, Key roles in vaccine production 32

Table 6: Manufacturing of Vaccines, Functions of Logistics Managers 37

Table 7: Manufacturing of Vaccines, Global Production Capacity (millions), 2003-2010 46

Table 8: Manufacturing of Vaccines, National Procurement and Suppliers of Vaccine 76

1.2 List of Figures

Figure 1: Manufacturing of Vaccines, Methods of Producing Vaccines 8

Figure 2: Manufacturing of Vaccines, Stakeholders for Vaccine Manufacturing 11

Figure 3: Manufacturing of Vaccines, Sales Model - Push The Demand 13

Figure 4: Manufacturing of Vaccines, Pharmaceutical Drugs Sales Model - Pull the Demand 13

Figure 5: Manufacture of Vaccines, Key Aspects of Packaging 16

Figure 6: Manufacturing of Vaccines, Inactivated Influenza Vaccines 19

Figure 7: Manufacturing of Vaccines, Inactivated Influenza Vaccines; Egg-Based Manufacture 21

Figure 8: Manufacturing of Vaccines, Advantages and Disadvantages of Inactivated Influenza Vaccine: Egg-Based Manufacture 22

Figure 9: Manufacturing of Vaccines, Advantages and Disadvantages of Inactivated Influenza Vaccine: Cell Culture-Based Manufacture 23

Figure 10:Manufacturing of Vaccines, Advantages and Disadvantages of Live Attenuated Influenza Vaccines: Egg-Based Manufacture 24

Figure 11: Manufacturing of Vaccines, Upstream Bioprocessing 27

Figure 12: Manufacturing of Vaccines, Quality Check 30

Figure 13: Manufacturing of Vaccines, Benefits of PAT, 2010 33

Figure 14: Manufacturing of Vaccines, Technologies used in Vaccine Manufacturing 34

Figure 15: Manufacturing of Vaccines, Unmet Needs in Vaccine Manufacturing 40

Figure 16: Manufacturing of Vaccines, Unmet Needs-Cost 41

Figure 17: Manufacturing of Vaccines, Unmet Needs-Time 42

Figure 18: Manufacturing of Vaccines, Influenza Vaccine Time Line 2010 43

Figure 19: Manufacturing of Vaccines, Global Unmet Needs 2010 44

Figure 20:Manufacturing of Vaccines, Global Vaccine Production Capacity in millions, 2003-2005-2010 47

Figure 21:Manufacturing of Vaccines, Drivers and Restraints of Vaccine Manufacturing Process 48

Figure 22: Manufacturing of Vaccines, GlaxoSmithKline, 2011 51

Figure 23: Manufacturing of Vaccines, Sanofi Pasteur, 2011 52

Figure 24: Manufacturing of Vaccines, Pfizer, 2011 53

Figure 25: Manufacturing of Vaccines, Merck, 2011 54

Figure 26: Manufacturing of Vaccines, Novartis, 2011 55

Figure 27: Manufacturing of Vaccines, CSL Limited, 2011 56

Figure 28:Manufacturing of Vaccines, Features and Benefits of Filtration Technology, 2011 58

Figure 29: Manufacturing of Vaccines, Contract Manufacturing Outsourcing, 2011 59

Figure 30: Manufacturing of Vaccines, Factors Critical in Manufacturing Strategies 60

Figure 31:Manufacturing of Vaccines, Comparison of In-house Facilities and Contract Manufacturing 61

Figure 32:Manufacturing of Vaccines, Advantages and Disadvantages of In-house Facilities 61

Figure 33: Manufacturing of Vaccines, Selection of CMOs 62

Figure 34: Manufacturing of Vaccines, GMP Standard 65

Figure 35: Manufacturing of Vaccines, Regulatory Landscape of Japan 67

Figure 36: Manufacturing of Vaccines, Singapore as a Hotspot 68

Figure 37: Manufacturing of Vaccines, Regulation Process of China, 2010 70

Figure 38: Manufacturing of Vaccines, China as a Hotspot 71

Figure 39: Manufacturing of Vaccines, India as a Hotspot 74

Companies Mentioned

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Drug and Medication Industry: Manufacturing of Vaccines - Cell Culture Technology Gradually Replacing Egg-Based Manufacturing

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