The 28,000 square foot facility, located in Shanghai’s Zhangjiang Hi-Tech business park, will aim to help customers optimize their upstream and downstream processes in addition to providing guidance on environmental monitoring.
EMD Millipore will also supply validation services to existing customers in the sector according to Jean-Paul Mangeolle, head of the firm’s process solutions business, who said that market need was the key driver for the opening.
“We are responding to China’s commitment to strengthen regulatory requirements designed to ensure drug safety,” Mangeolle explained, adding that “we can support and even train our pharmaceutical customers to meet the new Chinese and global regulations.”
The firm, which formed with Merck KGaA’s acquisition of Millipore in July, said that officials from China’s Food and Drug Administration (SFDA) and scientists from Peking University among the first group to receiving training.
“Both institutions will utilize EMD Millipore’s new Technical Center for training courses specifically created for GMP training and Aseptic process manufacturing.”
Merck KGaA told in-Pharmatechnologist.com that, in addition to the SFDA and Peking University, the facility will be available to biopharmaceutical developers that are not direct customers.
The new Shanghai facility is a continuation of the approach EMD and parent Merck have employed in other emerging manufacturing hubs like Singapore, Brazil and India.
The newest of these, excluding the Shanghai centre, is the facility in Nerul, Navi Mumbai, India. The site was opened in January this year as a support base for development services for applications ranging from chromatography for drug discovery.
And, as with the Shanghai opening, the firm stressed the Navi Mumbai centre’s provision of training and services to existing customers as the core focus of activities.
Whether EMD also sees these training centres as a way of expanding its customers is unclear, however, establishing the facilities must surely be of some benefit in this regard given that they also provide a showcase for its services.