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Biobanking: Key Operational, Regulatory and Ethical Trends Within the R&D and Commercial Landscape

  • Published: Oct-2018
  • Report Code: GBI091CBR
  • Report Format: pdf

Description

Table of Contents

1 Table of Contents 4

1.1 List of Tables 6

1.2 List of Figures 6

2 Introduction 7

2.1 What is a Biobank? 7

2.2 The Biobanking Process 7

2.2.1 Collection 7

2.2.2 Processing 8

2.2.3 Storage 8

2.2.4 Release 11

2.3 Best Practices 11

2.4 History of Biobanking 11

2.5 Types of Biobank 13

2.5.1 Population-Based Biobanks 13

2.5.2 Disease-Oriented Biobanks 15

3 Operating models of Public and Private Biobanks 17

3.1 Definitions of Public and Private Biobanks 17

3.2 Financial Arrangements 17

3.2.1 Public biobanks 17

3.2.2 Private Biobanks 18

3.3 Operational Processes 19

3.3.1 Donor Recruitment and Sample Collection 19

3.3.2 Sample Processing and Storage 20

3.3.3 Access (Release of Samples) 20

4 Legislative Framework for Biobanking 22

4.1 Regulatory Framework in Europe 22

4.1.1 United Kingdom 23

4.1.2 France 23

4.1.3 Germany 23

4.1.4 Spain 24

4.1.5 Italy 24

4.2 Regulatory Framework in North America 25

4.2.1 United States 25

4.2.2 Canada 26

4.3 Regulatory Framework in Asia-Pacific 26

4.3.1 Japan 26

4.3.2 China 26

4.3.3 South Korea 28

4.3.4 Australia 29

5 Ethical and Social Issues 32

5.1 Consent Limitation 32

5.2 Privacy and Discrimination Concerns 33

5.3 Ownership 33

5.4 Returning Research Results and Incidental Findings 34

6 Key Drivers and Barriers to Biobanking 36

6.1 Drivers 36

6.1.1 Developments in Genomic Research 36

6.1.2 Industry Focus on Drug Discovery and Development 36

6.1.3 Growing Interest in Regenerative Medicine 37

6.2 Barriers 39

6.2.1 Financial Issues 39

6.2.2 Lack of Harmonization between Countries 40

6.2.3 Social and Ethical issues 40

7 Emerging Trends in Biobanking Services 41

7.1 Stem Cell Biobanking 41

7.1.1 Adipose Tissue-Derived Stem Cells (ADSC) 41

7.1.2 Bone marrow-derived stem cells (BMSC) 45

7.1.3 Umbilical Cord Blood-Derived Stem Cells (UCBSC) 50

7.2 Cord Blood Banking 55

7.2.1 Operating model 56

7.2.2 Regulation 56

7.3 DNA/RNA Biobanking 58

7.3.1 Case Study – 23andMe 58

8 Company Profiles 60

8.1 AllCells 60

8.2 BioIVT 60

8.3 Bioserve 61

8.4 Cryo-Cell International 61

8.5 FUJIFILM Cellular Dynamics 61

8.6 PrecisionMed 62

8.7 ThermoFisher Scientific 62

8.8 Tissue Solutions 62

8.9 ViaCord 63

9 Conclusion 64

10 Appendix 65

10.1 References 65

10.2 Abbreviation List 71

10.3 GBI Research Report Methodology 72

10.4 Contact Us 72

10.5 Disclaimer 72

 
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