Boehringer expands 'bio-presence' in Shanghai
Print Edition
THE biopharmaceutical sector is one of the seven key industries according to China's 12th Five-Year Development Plan (2011-2015) and the industry is expected to grow an average of 20 percent annually through 2013 to 2015.
China will also encourage vaccine and new biomedicine development to foster the growth of a number of domestic companies with annual output value of tens of billions of RMB and raise Chinese companies' market share in the international market.
China Chamber of Commerce for the Import and Export of Medicines and Health Products had pointed out that the majority of China's biopharmaceutical companies are producing generics products and the industry needs to enhance research and development capabilities to have their own innovative biomedicines.
German pharmaceutical company Boehringer Ingelheim last year announced a 500 million yuan (US$81.4 million) joint investment with Shanghai Zhangjiang Biotech and Pharmaceutical Base Development Co to build up a cGMP biopharmaceutical manufacturing facility to provide development, clinical and commercial material and services to local and multi-national customers. Dr.Wolfgang Baiker, member of Boehringer Ingelheim's board of managing directors who's responsible for biopharmaceuticals and operations, talked to Shanghai Daily about the strategic considerations for setting up this biopharmaceutical facility and the overall industry trend in the country.
Q: What's your plan for the biopharmaceutical facility and the biopharmaceutical contract manufacturing businesses in China?
Boehringer Ingelheim plans to become a leader for contract development & manufacturing of monoclonal antibodies and recombinant proteins in China and to establish a platform for our own New Biological Entities and Biosimilars.
We have committed to build a biopharma manufacturing footprint for high-quality products in China. The first phase toxicology and early clinical supply Bio-Lab, which will be ready for operation in the third quarter this year, will have cell-culture preparation, single-use technology based upstream and downstream production line as well as isolator-based manual fill and finish function.
Our GMP facility for clinical and early commercial supply in a partnership with Zhangjiang Base Company in Shanghai plan to be ready by 2016. After the facility is fully operational, we are able to supply the full range of development and clinical services up to commercial supply to customers including local biopharmaceutical companies who have made earlier research input but find it too expensive to establish large scale manufacturing capability.
Q: The Shanghai facility is the fourth biopharmaceutical production site for Boehringer Ingelheim around the globe. Why do you set up a new one in China? Do you intend to move your production capacity from overseas production sites or are you seeking local clients?
Since 1984, we have made commercial supply to 22 biopharmaceutical products锛宻ix of them were manufactured and marketed by ourselves while 16 of them were under contract manufacturing deals with customers. The biotech industry in China is booming. We have learned that if we want to provide services to customers, we have to be close to the customers.
The primary aim of the project is to collaborate with Chinese biological startups so that they could have a reliable and high quality manufacturer. It's not our intention to build a new manufacturing base here and simply bring in our overseas existing contracts to China.
There's still no regulation to allow contract manufacturing for biopharmaceutical products in China so far. We're working with Zhanjiang Biotech and Pharmaceutical Base Development Co and Shanghai government to develop small scale pilot projects to demonstrate that with appropriate quality measures we'll be able to deliver good results, and we hope to get the approval by the end of this year.
Q: While some multinational drug companies are faced with the pressure from the expiration of patent drugs, some of the companies are considering entering the biosimilar businesses. How do you intend to balance your capacity between the research and development efforts to find new biological entities and biosimilar businesses?
It's our strategic intention to be active in all three sectors, not only biosimilars but also new biological entities and contract manufacturing business.
With a diversified portfolio in each of those three sectors, we'll make sure we have appropriate capacity for our customers as well as for internal projects.
Q: What's lacking in China's biopharmaceutical business and what are the major differences between Chinese biopharmaceutical companies and overseas ones?
Currently Chinese biopharmaceutical companies are generally on small scale because they don't have the capability or demand for large scale production and also because cell culture manufacturing is a technology-demanding business which requires very experienced staff.
We want to bring our expertise into China because we want to help local companies to achieve a jumpstart in terms of technology and quality standard so that they can gradually grow from small scale to large scale manufacturing.
From our observation the majority of Chinese companies are dedicated in the area of biosimilars锛 however some of them are also active in new biological entities' research and we're also aiming to partner with these companies to finally bring their products to the market.
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