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Agnes Shanley is senior editor of BioPharm International.
Technology vendors are strengthening their positions in China as the nation emphasizes self-sufficiency in research, development, and manufacturing.
Biopharmaceutical manufacturing figures prominently in China’s industrial plans. A growing population (the world’s largest), healthcare spending in the vicinity of $US 4.6 trillion (roughly 6% of the nation’s gross domestic product), and strong support for innovation have resulted in growth that has surpassed previous predictions, according to Eric Langer, director of BioPlan Associates, which recently published its second edition of Advances in Biopharmaceutical Technology in China (1).
According to BioPlan, the Chinese biopharmaceuticals market exceeded $9 billion in 2018, most of it for monoclonal antibodies (mAbs). Of the 27 mAbs that have been approved in China, nine are already manufactured locally, and over 400 mAbs are now in development, Langer wrote in February 2019 and November 2018 in the Market Research Blog (2,3). Currently, the country’s biopharmaceutical manufacturing base incorporates 180 biopharmaceutical manufacturing plants with more than 800,000 L of capacity, BioPlan research has found.
The country has 650 clinical trials underway for biologics. In 2015, the number of biologics patents filed, which had already begun to exceed US filings in 2011, was almost twice as large as the US figure, Langer wrote (3). WuXi Biologics, China’s largest contract research and contract development and manufacturing organization (CRO and CDMO) is building capacity in the United States and Singapore (4,5), but also plans to build a 1.6-million-ft2 facility in Shanghai (6). Global technology vendors are strengthening their presence in China, as shown by some recent developments.
During the last quarter of 2018, GE Healthcare and Wego Pharmaceuticals joined forces to provide a source of single-use consumable bioprocessing equipment in Weihai, China. The equipment is based on GE’s Fortem platform (7).
Pall Corp., which established its first Center of Excellence in China in 2013, set up a Biotechnology Integrated Solutions Center of Excellence in Shanghai in December 2018. The center will offer consulting services, demonstrate technology, and provide testing and training (8).
In December 2018, Sartorius Stedim Biotech (SSB) began a partnership with China’s Immunochina Pharmaceuticals, a specialist in immunotherapies, that will provide it with preferred access to SSB’s platforms for development, scale-up, and manufacturing (9).
In October 2018, Millipore Sigma revealed plans for its first single-use manufacturing facility in China. Using the company’s Mobius platform, the facility in Wuxi will provide both off-the-shelf and custom solutions (10).
Thermo Fisher Scientific opened its first analytical Bioprocess Design Center in Shanghai during the last quarter of 2018, part of its plan to establish a center of excellence in China. The 2700-m2facility offers access to bioprocess analytics equipment and to relevant expertise, with the goal of facilitating end-to-end bioprocess development (11).
1. V. Xia, “China’s Biopharmaceutical Growth: Can it Continue?” pharmamanufacturing.com, January 2, 2019.
2. E. Langer, “China Biopharmaceutical Growth Exceeding Western Expectations,” marketresearch.com, November 28, 2018.
3. E. Langer, “Can China Become a Top Destination for Biologics Manufacturing?” February 11, 2019.
4. PharmTech Editors, “WuXi Biologics Builds US Biologics Production Facility,” PharmTech.com, June 16, 2018.
5. PharmTech Editors, “WuXi Biologics to Invest $60-Million in New Singapore Biopharmaceutical Manufacturing Facility,” PharmTech.com, May 23, 2018.
6. D. Stanton, “WuXi Building Twelfth Plant as Biologics Contracts Ramp Up,”bioprocessinternational.com, November 22, 2018.
7. PharmTech Editors, “GE Healthcare Manufactures Single-Use Consumables in China," PharmTech.com, November 12, 2018.
8. Pall Corp., “Pall Opens Center of Excellence in Shanghai, Press Release, December 18, 2018.
9. Sartorius-Stedim, “Sartorius and Immuochina Partner to Advance Immunoptherapy Development,” Press Release, December 3, 2018.
10. Millipore-Sigma, “Millipore Sigma to Open China’s Firs Mobius Site,” Press Release, September 11, 2018
11. Thermo-Fisher Scientific, “Thermo-Fisher Opens New Bioanalytics Center in Shanghai,” Press Release, November 30, 2018.
Vol. 32, No. 3
When referring to this article, please cite it as A. Shanley, “Strategic Ventures Reflect Dynamic Growth in China," BioPharm International 32 (3) 2019.