- Boehringer Ingelheim said Thursday it has started to expand capabilities at its biologics facility in Shanghai.
- The expansion includes an additional bioreactor and the infrastructure to support two 2,000-liter single-use bioreactor production lines. Boehringer said the new operations should meet Good Manufacturing Practice (GMP) standards.
- While the facility has yet to manufacture commercial supply for any products, that should change later this year as Boehringer expects to begin production on an undisclosed monoclonal antibody.
U.S. and European pharmas see big market opportunities in China. There, the regulatory landscape has undergone slow but considerable change, which in recent years has allowed for less burdensome clinical development — though plenty of barriers remain.
Showcasing that trend, Hutchinson China MediTech in early September secured the first unconditional Chinese approval of a cancer drug both discovered and developed in the country.
In the months since, Sanofi made China a more prominent part of its business, AstraZeneca got a thumbs up from the country's national drugs regulator for its anemia medicine, and China-based Beigene bought a biologics manufacturing plant from GE Healthcare to ramp up monoclonal antibody production.
Boehringer, itself one of the world's largest contract manufacturers, opened its OASIS facility in Shanghai in May 2017 after spending more than 70 million euros. Little over a year later, the company revealed plans to add a new fill-and-finish line that could meet GMP standards.
It appears with Thursday's announcement that Boehringer is far from finished growing its business in China.
"[W]e see a growing demand for world-class manufacturing capacities of biologics and are eager to offer our capabilities to local and global customers according to our site supply mission 'China-for-China' and 'China-for-Global,'" said Jiali Luo, general manager and site head of Boehringer Ingelheim Bio China, in a Jan. 17 statement.