The prefabricated cGMP facility is the result of a partnership between GE Healthcare and the three year-old Chinese JHL Biotech. The prebuilt modules containing biowaste treatment facilities and clean rooms within a 2,400m2 floor space were shipped from Stuttgart, Germany to Wuhan in China’s Hubei province in August. Bioreactors and chromatography equipment are expected to arrive between December and January.
Racho Jordanov, JHL CEO, told BioPharma-Reporter.com the site should be up and running by June – largely because the set-up allows validation to begin before the site has completed construction.
Validation for air conditioning, clean rooms, and other operational qualifications can begin while the building is still being installed, while engineers in Sweden will remotely perform validate chromatography.
The process is extremely similar to that in JHL’s modular Taiwan factory which has been operating for more than two years. “We’re very familiar with the equipment, it’s just a different size. We know the software and the operating procedure,” said Jordanov.
JHL and GE plan to add a second manufacturing studio and a fill-finish plant to the Wuhan campus. Jordanov said his company has also been in talks to bring the modular tech to Vietnam.
Demand: national healthcare systems
Jordanov told us the pre-built, pre-validated model appeals to states seeking self-sufficient, low-cost pharma production.
“Our goal is to improve the speed to market and cost of the product by innovation, not by saving dollars on labour because we’re in China. We’re in China because the Chinese government requires that we manufacture products in China, even for IND [investigational new drug] submissions. If you want to be in the Chinese market and if you want to be treated as a domestic company, you have to be in China.
“My experience has been that countries that have national healthcare under pressure for the cost of very expensive biopharmaceuticals will try to adopt the technology so they’re not reliant on big pharma in Europe and the US.”
The trend echoes Brazil’s PDP (productive development partnerships) scheme, he said. The government contracts guarantee market share to API and drug manufacturers in exchange for a discount on the goods. “Similar things although not so formalised are happening all over China and southeast Asia. China is so huge that every province is almost like a country.
“The province where we are [Hubei] is 80 million people. So that’s a good-sized European country. Every government, even the provincial govt has an interest in reducing the cost of the imported medication. So we received support from china and Taiwan for being there. I think governments will continue at least for the next ten or twenty years to support the development of biotech in their countries.”
JHL and GE also told us the facilities could be used by governments to prepare for pandemics – a way to “stockpile capacity rather than stockpile a particular vaccine,” as one GE spokesman put it.
“I think it’s feasible to add capacity very quickly in regions of the world where the epidemic is flaring fastest,” said Jordanov.
“I think [modular manufacturing would] be a very useful concept when time is of the essence, because if you look back on history, Tamiflu was the only effective medication for the SARS pandemic; when Roche approached China for supplies, China requested the technology be transferred to China in order to manufacture.”