China is keen to establish itself as a presence in the biologics sector and, in a similar way to Singapore, the government is prepared to use its finances and influence to ensure this happens.
Julius Li, the CEO of AutekBio, the contract manufacturing organisation (CMO) leading the venture, told Outsourcing-Pharma that the project turned to the Chinese government when capital dried up during the economic downturn.
Buoyed by governmental support AutekBio has outlined its plans. Li explained that the 60-70,000 sq m site will house manufacturing facilities producing biologics at scales ranging from preclinical to commercial.
The largest bioreactors at the site will be around 20,000L, some way short of the 80,000L capacity at Lonza’s site in Singapore, but Li believes the scope of the Beijing facility gives it a legitimate claim of being the largest contract biologics plant in Asia.
In addition to preclinical through to commercial scale manufacturing the site will also house process development. Completion of construction of these different capabilities will occur in phases in the coming years.
First, the pilot plant will begin operating at some point in 2010. This will be followed within three years by 1000L reactors. Finally, within four years the largest bioreactors will begin production.
Hiring and compliance
When all these aspects are fully operational Li believes the site could employ up to 1,000 people. AutekBio is looking to recruit leaders from the US and Europe, citing the lack of experience China has in managing this type of operation, but other positions will be filled by locals.
Beijing alone produces a large number of life science graduates each year which can fill some positions and Li also hopes some Chinese people will return home from biotech jobs overseas.
Li strongly believes that Chinese engineers are the best in Asia, adding that many are already employed in Singapore. This combination of leadership with experience of managing biologics production and skilled operators is designed to ensure the site runs to international standards.
Achieving compliance with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) current good manufacturing practice (cGMP) guidelines is integral to the sites plan.
Li hopes the site will serve a range of businesses, from large, multi-national pharmas to local firms, small biotechs to biogeneric producers, adding that many companies have already shown an interest.
China’s biologics roadmap
The Chinese government has been supportive of the project, offering favourable land prices, loans and training. This has come from local, as well as national, government, with Li explaining that Shanghai and Beijing both competed to house the production site.
Shanghai and Beijing, like many regions around the world, are keen to establish a biotech industry and Li expects competition to intensify in coming years. He explained: “It is my goal that 10 per cent of the world’s biomanufacturing capacity will be in China within the next 10 years.”