According to Boehringer-Ingelheim (BI), the company has established the “first and only biopharmaceutical facility established by a leading multinational active biopharmaceutical manufacturer in China utilizing mammalian cell culture technology.” The first-phase investment of more than $78 million (€70 million) adds to its existing Good Manufacturing Practice (GMP) clinical material supply capabilities and expands the global reach of BI’s Boehringer Ingelheim BioXcellence™ contract manufacturing business, which already operates at commercial scale in Biberach (Germany), Vienna (Austria) and Fremont (USA).
The facility, which is located in Zhang Jiang Hi-Tech Park in Shanghai, supports both drug substance and drug product manufacturing and is outfitted with 2000L single-use bioreactors and fill/finish systems. It has also been designed with the flexibility to add more bioreactors and fill/finish operations. BI’s intention is to become “a leader for contract development and manufacturing of monoclonal antibodies and recombinant proteins in China.” Clinical trial manufacturing in China currently takes place at the 100L and 500L scales.
“As a global leader in biopharmaceutical contract manufacturing, Boehringer Ingelheim has an extraordinarily long history in the field of biotechnology, having been in the industry for over 35 years,” said Dr. Luo Jiali, General Manager of Boehringer Ingelheim Biopharmaceuticals (China) Co Ltd. “We offer tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to the finished product under one roof. With our strong know-how, global network, technology, and international quality standards we can support innovative Chinese and international companies to industrialize their research results.”
Hubertus von Baumbach, Chairman of the Board of Managing Directors at Boehringer Ingelheim, added to this, saying, “Our Shanghai facility plays an important role in our globally leading biopharmaceutical contract manufacturing business and embodies our continuous and long-term commitment to China. With this investment, we expect to have a significant impact on the development of China’s biopharmaceutical industry to ultimately supply innovative medicines to patients following high quality standards.”
BI currently employees approximately 50,000 people around the world in its human pharmaceuticals, animal health and biopharmaceutical contract manufacturing businesses. Boehringer Ingelheim BioXcellence™ has been operating for over 35 years and has manufactured more than 25 products. It provides customers support across the entire drug development cycle “from DNA to fill and finish.”
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