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Advances in Biopharmaceutical Technology in China

Advances in Biopharmaceutical Technology in China

NEW, updated Advances in Biopharmaceutical Technology in China, 2nd ed., co-publication with Society for Industrial Microbiology & Biotechnology and BioPlan Associates, Inc., provides an authoritative analysis of the biopharmaceutical industry, and the state of China's technology. With 102 recognized authors in 55 chapters, and 7 briefs, this study provides the most objective view of the opportunities in China today.

Peer-reviewed, 1,139 page reference and analysis: Develop your China Strategy, Improve your decision-making & investment in China, Assess technology and biomanufacturing operations, In-depth analysis of capacity, trends, benchmarks, and much more.

BY THE NUMBERS

  • 102 Internationally Recognized Authors
  • 21 Peer-Reviewers
  • 1,157 Pages
  • 70 Translated Chapters
  • 5 Case Studies and China Briefs
  • 102 Authors
  • 66 Different Institutions represented
  • 200+Tables and Figures
  • 300+ References
  • Over 2,000 Index Entries


STUDY OVERVIEW
SECTION 1 INTRODUCTION TO ADVANCES IN CHINA BIOPHARMACEUTICALS
1 Intro Introduction: A China Biopharmaceuticals Strategy
SECTION 2 INNOVATION IN CHINA BIOPHARMACEUTICALS: HISTORICAL AND CURRENT CLIMATE
2 Intro Biologics Innovation in China: Historical and Current Drivers
2.1 Chinese Innovation in the Biopharmaceutical Industry, 2007 to 2016
2.2 Scientific Strategy in China: Starting with Biosimilar Platforms
2.3 Development of Innovative Therapeutics in China
2.4 Opportunities and Challenges for Drug Innovation in China
2.5 Pathway for Access to China Markets for Innovative Therapeutics
2.6 China on the Biopharmaceutical Fast Track? Challenges to Innovation
2.7 Advances in R&D for mAb Therapeutics Development
2.8 Current Status and Future of China’s mAb Therapeutics
2.9 Brief Challenges and Opportunities in Innovative Drug Development in China
2.10 Brief Launching Biologics in China: From Biosimilar to Innovative Molecules.
2.11 Brief Accelerating R&D of Biological Drugs in China
2.12 Brief China's Biopharma Innovation--Creating Opportunities
2.13 Brief Tech Advances in Biopharma
SECTION 3 BIOKPHARMACEUTICALS AND HEALTHCARE SYSTEMS AND STRUCTURE IN CHINA
3 Intro Overview and Review of the Chinese Biological Pharmaceutical Markets
3.1 Reform of Drug and Medical Device Review and Approval Systems
3.2 China’s Regulatory Reform in Healthcare: Achievements and Challenges
3.3 China Food and Drug Administration Reform in China
3.4 Reforms and Trends in China’s Healthcare Insurance System
3.5 New Drug Evaluation Systems in China
3.5 Approval Process for Biologics: A US-China Comparison
SECTION 4 BIOPHARMACEUTICAL MANUFACTURING IN CHINA: OPERATIONAL AND QUALITY TRENDS
4 Intro Introduction to BioManufacturing in China
4.1 Manufacturing of Biopharmaceuticals in China
4.2 Historical Development of Good Manufacturing Practices in China
4.3 Current Challenges in Biopharma Quality Management in China
4.4 National Standards for Chinese Biological Products
4.5 Advances in China Pharma Manufacturing
4.6 Recombinant Protein Drug Quality Control
4.7 GMP Implementation: The “Made in China 2025” Plan
4.8 Single Use Technology in China’s Biomanufacturing
4.9 Biologics Manufacturing Costs in China
4.10 Impact of CFDA Reform on CMC Strategy at IND Stage
4.11 Overview of Biopharmaceutical Contract Manufacturing Organizations in China
4.12 Establishing a Management Pattern for Pharmaceuticals Using the Enterprise Resource Planning System
4.13 Bioprocessing Equipment Strategy in mAb Manufacturing in China
4.14 Tech Transfer in mAb Manufacturing
4.15 Brief Advances in the Biopharmaceutical Manufacturing Industry in China
SECTION 5 ADVANCES IN BIOLOGICAL DEVELOPMENT IN CHINA
5 Intro Introduction to Biological Development in China
5.1 Monoclonal Antibody Drug Development in China
5.2 Development of Antibody-Drug Conjugates in China
5.3 Therapeutic Developments for Rare Diseases in China
5.4 CarT-China: Advances in Personalized Medicine
5.5 RNAi in China: Novel Therapeutics in China
5.6 Clinical Trials and Regulatory Oversight of Mesenchymal Stem Cell Therapies in China
SECTION 6 VACCINE INDUSTRY IN CHINA
6 Intro Introduction to China’s Vaccine Industry
6.1 Historical Review of China Vaccines: 2007-2016
6.2 Innovative Developments in China’s Vaccine Industry
6.3 China’s Vaccine Industry: Current Landscape and Key Product Segments
6.4 Current State and Overview of the Chinese Vaccine Market
SECTION 7 BIOPHARMA CONTRACT SERVICES AND CLINICAL TRIALS IN CHINA
7 Intro Introduction to China’s Services to the Biopharma Industry
7.1 Conducting International Multicenter Clinical Trials in China
7.2 Current and Future Development of CROs in China
7.3 Future of CRO’s in China: An Investor’s Point of View
SECTION 8 DOING BUSINESS IN CHINA: INVESTMENT AND INTELLECUTUAL PROPERTY
8 Intro Introduction to Investing in China Pharma and Biopharma Industry
8.1 IP and Biopharma in China
8.2 Trends and Characteristics of Intellectual Property in China’s Biopharmaceutical Industry
8.3 Investing in the Biopharmaceutical Industry in China
8.4 An Invitation to Invest in Biomedicine in China
8.5 China’s Investment Outbound in the Global Biopharmaceutical Industry
8.6 International Status and Path Analysis of China's Pharmaceutical Products
8.7 China Licensing Deals for Biologics
8.8 Legal Issues: Commercial Bribery in Pharmaceutical Companies in China
8.9 Marketing Authorization Holder Options Under Cost Control
8.10 Industrial Policy and Technology Transfer in China’s Biopharma Industry
8.11 Slow Transformation: An Overview of China Pharmaceutical Business
8.12 Brief Intellectual Property Trading in China’s Pharmaceutical Industry
8-13 Case Study: Doing Business in China
SECTION 9 FUTURE OF CHINA'S BIOPHARMA INDUSTRY
9.1 Future Prospects for China Biopharma
APPENDICES
Appendix A Directory of Biologics on Market & Clinical Development in China
Appendix B Directory: Top 60 Biopharmaceutical Facilities in China

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