HONG KONG – Wuxi Pharmatech Inc. is building a $150 million biologics manufacturing facility for subsidiary Wuxi Biologics – the largest of its kind in China. When finished, the new facility will put the company in a different league, multiplying its production capacity and doubling its client base. Perhaps more importantly, it signals an advance for China's drug development sector, which historically has been handicapped in efforts to develop biologics.

"In general, the increase [of the biologics manufacturing capability] will be sixfold," Chris Chen, Wuxi's senior vice president and chief technology officer of the biologics services department, told BioWorld Asia. "In reality, on the output side, it's actually more. In terms of volume, it will be five [times]."

The new factory will be built next to the company's existing manufacturing facility set up in August 2012 in Wuxi City, Jiangsu Province. A key feature of the new site is its use of disposable bioreactors with disposable bags instead of culture vessels.

"This is actually a next-generation manufacturing technology," said Chen. "Because they're disposable, it's a lot easier to operate so we can build the facility faster."

A key aim for the new factory is to make it "very flexible so we'll be able to run future processes; we have these new design ideas that allow us to do continuous manufacturing and semi-continuous manufacturing," Chen added. "This is also very unique."

Not only will the new facility be the largest biologics factory in China, Wuxi also said it will be the largest mammalian cell culture manufacturing facility in the world when it is completed.

Wuxi's current biologics clinical drug substance and drug product manufacturing facilities are the first in China that met cGMP standards from the U.S., EU and China.

The new factory will house 14 2,000-liter disposable bioreactors for fed-batch cell culture and two 1,000-liters bioreactors for perfusion runs. Wuxi Biologics' current total direct volume is 5,500 liters. The new facility will add another 30,000 liters when it starts operating in January 2017.

"We have included the initial qualification time of the new facility when we say it will be completed by January 2017," said Chen. "We'll start manufacturing for our clients by then, but for research manufacturing, sometimes the U.S. FDA or EMA will not come [for inspection] until later on."

Wuxi Biologics now serves about 10 to 15 clients in the biologics manufacturing area every year making clinical drug substance and drug product for both international and domestic companies.

"The new facility will at least double our client base," said Chen. "Also there's a difference [in the purpose of manufacturing]. Currently we're only doing clinical manufacturing; the new facility is the beginning of our much larger-scaled commercial manufacturing."

Wuxi is the manufacturer of the first China-made biologic used in U.S. trials. The drug, ibalizumab (TMB-355), was developed by Taiwanese drugmaker Taimed Biologics Inc. and received U.S. breakthrough designation in March. (See BioWorld Today, March 4, 2015.)

Wuxi provides clinical supply manufacture and process validation for ibalizumab. If approved, the drug will be the first China-manufactured biologic product launched in the U.S.

Like Taimed, Wuxi has built up long-term and comprehensive partnership with many clients. A lot of the clients assigned their manufacturing to Wuxi after the company helped them with early stage discoveries and development.

"One of the reasons we're successful at manufacturing is actually because we have a lot of R&D programs so we have built our own client pipeline this way," said Chen. "We started [with our clients] on R&D and eventually they will need us to manufacture for them."

Chen said the new facility would only be used for manufacturing among the extensive services the company offers. In addition, Wuxi's new facility will only manufacture mammalian cell-based biological products such as antibodies, enzymes and proteins leaving out microbial-based products such as yeast-based products.

"Investment in this state-of-the-art biologics commercial facility of the future is another milestone for Wuxi Biologics," said Ge Li, chairman and CEO of Wuxi. "This project continues to strengthen Wuxi's capabilities in integrated biologics discovery, development and manufacturing services."