Sourcebook Table of Contents

 

2017 Biopharma Cold Chain Sourcebook

Table of Contents 
1     Executive Summary

2017 cold-chain logistics forecast (Chapter 3)      11
2017 clinical trials logistics forecast (Chapter 8) 13
Cold chain regulation (Chapters 4-5)    14
Logistics service providers and carriers (Chapter 6)     15
Packaging, instrumentation, specialized markets (Chapter 7)    15

2     Historical Background – Origins of Cold Chain 17

3     Cold Chain Logistics Forecast to 2021   21
3.1 Drivers of Growth in Temperature-Sensitive Drugs, Biologics and Cellular Therapeutics  21
Global pharma industry growth trend     22
New drugs   27
US trend    29
Biotech drugs    30
Biosimilars 32
Blood and plasma products    33
3.2   Cellular Therapies     33
Commercialization of cellular therapies 34
CAR-T market     34
Stem cells  36
Overall Cold-Chain Biopharma Sales Forecast   38
Future direction 40
3.3   Distribution Dynamics  42
Regulatory background  43
Distribution channels  44
Modes of transport     46
Europe      47
World trade trends     50
US trade trends  53
Logistics business trends    55
3.4   Cold-Chain Logistics Market Sizing and Forecast     57
Risks and opportunities      60

4     Regulatory Environment 61
4.1   Global Regulations and Guidelines 63
4.2   European Union   65
European GDP Guidelines      65
Quality assurance in European Union good manufacturing practice      66
A perspective on enforcement from the UK      67
4.3   United States    68
US enforcement   69
USP <1079> “Good Storage and Shipping Practices” and quality
management  70
Other US laws and regulations      72
4.4   Canada, Ireland, Australia   72
Canada      72
Ireland     73
Australia   74
4.5   China and Other Developing Markets 74
China’s revised GSP    75
Brazil’s regulations for biologics 77
Mexico’s import controls     77
Argentina’s cold-chain temperature indicator law    78
Singapore’s GDP guidance     79
United Arab Emirates’ instructions 79
Israel      79
Saudi Arabia     80
India, and other markets     81
4.6   Product Integrity 82
‘Falsified’ medicines and supply chain traceability 82
EU Falsified Medicines Directive  83

5     Guidance for Cold-Chain Handling  85
5.1   Parenteral Drug Association (PDA) 86
PDA Technical Report 46, Last Mile: Guidance for Good Distribution   Practices for Pharmaceutical Products to the End User   87
Other PDA Guidances    90
5.2   World Health Organization (WHO)    90
WHO “model guidance” for the cold chain 91
WHO vaccine guidelines 91
5.3   International Air Transport Association (IATA)      94
IATA Standard Acceptance Checklist 94
IATA Center of Excellence for Independent Validators (CEIV)    95
5.4   Other Guidances  97
US Centers for Disease Control and Prevention (CDC) 97
Healthcare Distribution Management Association (HDMA)    97
International Safe Transit Association  98
6 Third-Party Logistics Providers, and Carriers     101
6.1   3PL Market Trend and Top Companies 104
6.2   Global View of Economic Recovery and logistics      106
6.3   Top 3PLs    107
UPS   107
Deutsche Post-DHL 108
FedEx 109
Kuehne + Nagel   110
Other top 3PLs   110
Specialized suppliers  111
6.4   Passenger + Cargo Air Carriers     111
United      112
Lufthansa   112
Delta Air Lines  112
American Airlines 112
IAG Cargo   113
Cathay Pacific   113
6.5   Ocean and Truck Transport    113
“Qualified” road transport   116
7     Specialized Packaging and Instrumentation     117
7.1   Carton Delivery  119
Pallet packaging 121
Active containers 123
Container variations   124
Thermal blanketing     126
7.2   Stability Testing; Stability Budget     127
7.3   Monitoring Instruments and Systems 129
Sensitech   132
Elpro-Buchs AG   132
TempTime    132
OnAsset     133
7.4   Controlled Room Temperature  134
7.5   Special Safety and Security Issues 135
8     Clinical Trials Logistics Forecast to 2021    137
8.1 Market Drivers     137
R&D trends  138
Clinical trials trend  140
Regional trend   140
8.2 Clinical-Trials Logistics Forecast to 2021      143
9     Active Pharmaceutical Ingredients (APIs)      147
9.1   API Products and Manufacturers     147
Ranbaxy, APIs and generic Lipitor 148
Atorvastatin calcium   148
9.2   API Regulations and Guidances      150
WHO “Good trade and distribution practices for pharmaceutical
starting materials”    150
European Commission draft GDP for APIs  150
European Union directive on falsified medicines as it affects APIs   151
9.3   Global Trade and Transport of APIs 153
9.4   Specialized Packaging for APIs     155
Vendor and Service Provider Directory   157

Vendors and Service Providers      157

Vendors and Service Providers by Product & Service Category    172

Figures     177

Tables      180

References  183

 

The Biopharma Cold Chain Sourcebook 2017 is available for purchase at US$1495.
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