Wuxi Griffin, a joint venture between China’s Wuxi Fortune Pharmaceutical Co and Sweden’s SialoCarb AB, is preparing to take advantage of changing Chinese contract manufacturing organisation (CMO) policies by offering sterile fill and finish services from a 2550m2 facility in Wuxi City, 80km west of Shanghai.
Historically, CMOs have not been permitted to operate in China. However, according to Wuxi Griffin marketing manager Diana Lam recent changes in legislation have opened the door to foreign CMOs establishing themselves in China.
On May 26 2016, China’s State Council began allowing drug Marketing Authorization Holders (MAH) without their own production capabilities to use third-party licensed and GMP-compliant manufacturers in ten provinces: Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, and Sichuan. The announcement can be found here in Mandarin.
“With regards to Chinese CMOs complying to western GMP, there are less than ten that we are aware of,” Lam told this publication, but the regulation makes it “likely that more international CMOs will make an effort to establish presence in China.”
Furthermore, the rapid growth of the Chinese market is likely to accelerate this, with demand coming from companies and biotechs without their own facility (or the capex to build one), as well as firms wanting to expand internationally which lack the experience and competence regarding international standards.
Boehringer-Ingelheim
According to Lam, the first foreign CMOs to make its mark in China was Boehringer-Ingelheim, which began collaborating with local partners on a mammalian cell culture facility in Shanghai in 2013. The site opened last year, and this week the firm announced it was set to make the first commercial monoclonal antibody from the facility – and indeed the first by a multinational CMO – for its Chinese MAH partner BeiGene.
Ralph Warsinsky, a spokesperson from Boehringer-Ingelheim, told us his firm is currently “the only multinational CMO in China which provides GMP manufacturing services according to international standards.”
He added: “We are delighted that our experiences with our contract manufacturing operating model and GMP standards are acknowledged by Chinese authorities. These have supported the development of the regulatory reform in China, in terms of shaping the regulations on biologics outsourcing.”
He declined to comment on other companies’ plans to establish pharmaceutical manufacturing facilities in China.