Shanghai Filling Line is Latest Investment in China for B-I

Boehringer-Ingelheim will offer both drug substance and drug product services form its facility in Shanghai, China after adding fill & finish capabilities.

German drugmaker Boehringer Ingelheim has added a new filling line at its commercial biomanufacturing facility in Shanghai, bolstering its third-party business, BioXcellence.

“At our China facility the F&F [fill & finish] service complements the manufacturing service for drug substance at that site, meaning we can now offer drug substance and drug product out of one facility for our local and global customers,” spokesperson Heidrun Thoma told BioProcess Insider.

The expansion comes in response to growing demand from both Chinese and international customers.

“Our plant in Shanghai can supply both the local Chinese market as well as international markets, including the USA – this also applies for our F&F service,” Thoma said. “Before the start of commercial operation on May 16th, 2017, we have already been producing clinical trial supplies for international markets, including the USA, from the plant. “

The capacity of the fill & finish line has not been divulged, but Thoma said the new capabilities will not be offered as a stand-alone service.

Boehringer in China

According to the firm, Boehringer Ingelheim has invested more than €70 million (US$81 million) to build the cGMP biomanufacturing facility in collaboration with the Zhangjiang Biotech & Pharmaceutical BaseCompany in Shanghai (China). The firm has hired more than 100 employees to support the operations.

“The Shanghai facility comprises two stages of establishment: a pilot plant – BioLab, which has started operations since 2015; and a commercial plant – Oasis, which has all the equipment, systems and processes required for commercial cGMP manufacturing and has started to provide biopharmaceutical services to Chinese and international customers,” Thoma said.

“Oasis’ full production started in May 2017. Based on BioLab manufacturing capability, Boehringer Ingelheim has entered into contract manufacturing agreements with five customers and has successfully developed the customer portfolio for BioChina further.”

But Thoma added the Shanghai plant is just one of several global sites subject to investments and expansion to support biomanufacturing.

“We are also open for expansions in this field which is reflected in our current investments, e.g. into a large scale cell culture facility at Vienna, Austria, an expansion at our US site in Fremont, California, a new F&F line at our site in Biberach, Germany, and of course the investments in China.”

Last month, the firm pledged €230 million into a Biologicals Development Center (BDC) at its Research and Development site in Biberach, Germany.

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