Made in China: Boehringer-Ingelheim to make first mAb from new Shanghai plant
Germany-headquartered contract manufacturing organisation (CMO) Boehringer-Ingelheim announced yesterday it has entered into an agreement to commercially supply the anti-PD-1 antibody islelizumab for its Chinese partner BeiGene.
The monoclonal antibody will be the first to be made commercially from Boehringer’s mammalian cell culture facility in Pudong, Shanghai which opened its doors in May last year.
The site, built in collaboration with Zhangjiang Biotech & Pharmaceutical Base Development Company, is part of Boehringer’s strategy to “become a leader for contract development and manufacturing of monoclonal antibodies and recombinant proteins in China,” Boehringer spokesperson Ralph Warsinsky told Biopharma-Reporter.
This agreement marks the first biopharmaceutical made by a third-party manufacturer to enter into commercial supply in China, though Warsinsky said Boehringer has “already been manufacturing clinical trial supplies in Shanghai since 2015,”
Until recently, third-party manufacturers were not permitted to operate in China. A China State Council announcement in May 2016 (see here for details in Mandarin) allowed trial projects for Marketing Authorization Holders (MAH) to use a GMP-compliant CMO, effectively overwriting this rule.
According to Warsinsky, Boehringer, through its facility and partnerships, was a key player in helping to change the regulations.
“Establishing and expanding our biopharmaceutical manufacturing facility in Shanghai has been accomplished in close collaboration with local authorities and partners,” he told us.
“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.”
