Advances in Biopharmaceutical Technology
in China, 2nd Edition
NEW, updated Advances in Biopharmaceutical Technology in China, 2nd ed. provides an authoritative, peer-reviewed 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. Published in cooperation with the Society for Industrial Microbiology & Biotechnology.
Peer-reviewed, 102 global authors, 1139 pages:
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 Numbers102 Internationally Recognized Authors
9 Sections, 55 Chapters
21 Peer-Reviewers
1,139 Pages
7 Case Studies and China Briefs
200+ Tables and Figures
300+ References
Over 2,000 Index Entries
Chapters
SECTION 1 Introduction to Advances in China Biopharmaceuticals
Introduction: A China Biopharmaceuticals Strategy
SECTION 2 Innovation in China Biopharmaceuticals: Historical and Current Climate
Biologics Innovation in China: Historical and Current Drivers
Chinese Innovation in the Biopharmaceutical Industry, 2007 to 2016
Scientific Strategy in China: Starting with Biosimilar Platforms
Development of Innovative Therapeutics in China
Opportunities and Challenges for Drug Innovation in China
Pathway for Access to China Markets for Innovative Therapeutics
China on the Biopharmaceutical Fast Track? Challenges to Innovation
Advances in R&D for mAb Therapeutics Development
Current Status and Future of China’s mAb Therapeutics
Challenges and Opportunities in Innovative Drug Development in China
Launching Biologics in China: From Biosimilar to Innovative Molecules.
Accelerating R&D of Biological Drugs in China
China's Biopharma Innovation--Creating Opportunities
Tech Advances in Biopharma
SECTION 3 Biopharmaceuticals, Healthcare Systems and Structure in China
Overview and Review of the Chinese Biological Pharmaceutical Markets
Reform of Drug and Medical Device Review and Approval Systems
China’s Regulatory Reform in Healthcare: Achievements and Challenges
China Food and Drug Administration Reform in China
Reforms and Trends in China’s Healthcare Insurance System
New Drug Evaluation Systems in China
Approval Process for Biologics: A US-China Comparison
SECTION 4 BioManufacturing in China: Operational and Quality Trends
Introduction to BioManufacturing in China
Manufacturing of Biopharmaceuticals in China
Historical Development of Good Manufacturing Practices in China
Current Challenges in Biopharma Quality Management in China
National Standards for Chinese Biological Products
Advances in China Pharma Manufacturing
Recombinant Protein Drug Quality Control
GMP Implementation: The “Made in China 2025” Plan
Single Use Technology in China’s Biomanufacturing
Biologics Manufacturing Costs in China
Impact of CFDA Reform on CMC Strategy at IND Stage
Overview of Biopharma Contract Manufacturing Organizations in China
Establishing a Management Pattern for Pharmaceuticals Using the Enterprise Resource Planning System
Bioprocessing Equipment Strategy in mAb Manufacturing in China
Tech Transfer in mAb Manufacturing
Advances in the Biopharmaceutical Manufacturing Industry in China
SECTION 5 Advances in Biological Development in China
Introduction to Biological Development in China
Monoclonal Antibody Drug Development in China
Development of Antibody-Drug Conjugates in China
Therapeutic Developments for Rare Diseases in China
CarT-China: Advances in Personalized Medicine
RNAi in China: Novel Therapeutics in China
Clinical Trials and Regulatory Oversight of Mesenchymal Stem Cell Therapies in China
SECTION 6 Vaccine Industry in China
Introduction to China’s Vaccine Industry
Historical Review of China Vaccines: 2007-2016
Innovative Developments in China’s Vaccine Industry
China’s Vaccine Industry: Current Landscape and Key Product Segments
Current State and Overview of the Chinese Vaccine Market
SECTION 7 Biopharma Contract Services and Clinical Trials in China
Introduction to China’s Services to the Biopharma Industry
Conducting International Multicenter Clinical Trials in China
Current and Future Development of CROs in China
Future of CRO’s in China: An Investor’s Point of View
SECTION 8 Doing Business in China: Investment and Intellectual Property
Introduction to Investing in China Pharma and Biopharma Industry
IP and Biopharma in China
Trends and Characteristics of Intellectual Property in China’s Biopharmaceutical Industry
Investing in the Biopharmaceutical Industry in China
An Invitation to Invest in Biomedicine in China
China’s Investment Outbound in the Global Biopharmaceutical Industry
International Status and Path Analysis of China's Pharmaceutical Products
China Licensing Deals for Biologics
Legal Issues: Commercial Bribery in Pharmaceutical Companies in China
Marketing Authorization Holder Options Under Cost Control
Industrial Policy and Technology Transfer in China’s Biopharma Industry
Slow Transformation: An Overview of China Pharmaceutical Business
Intellectual Property Trading in China’s Pharmaceutical Industry
Case Study: Doing Business in China
SECTION 9 Future of China’s Biopharma Industry
Future Prospects for China Biopharma
Appendices
Directory of Biologics on Market & Clinical Development in China
Directory: Top 60 Biopharmaceutical Facilities in China
For more information, please contact us at 1+-301-921-5979, [email protected] or visit us at www.bioplanassociates.com. Electronic Versions Available. Published by BioPlan Associates, Inc. October 2018 | ISBN 978-1-934106-34-1