Coming to America: WuXi Biologics Expands Again

WuXi Biologics will construct its first biomanufacturing facility in the US. The US$60 million plant is the third overseas expansion announced in the past month by the Chinese CDMO.

Chinese contract development and manufacturing organization (CDMO) WuXi Biologics has rapidly begun expanding its biomanufacturing capacity. A string of investments over the past few weeks will add new capacity in China as well as see the firm venture overseas, including in the US where a US$60 million (€51 million) plant in Worcester, Massachusetts has just been announced.

“WuXi Biologics has always positioned us as a global company, so opening a site in the global center of biotech [Massachusetts] is a matter of time,” WuXi Biologics CEO Chris Chen told BioProcess Insider. “MA government has been in discussions with us for close to a year and has been supportive.”

The facility will be operational in the fourth quarter 2020, he added, and will employ around 150 staff.

MFG11, as it is to be known, will be the eleventh facility in WuXi’s growing network. Like the others (detailed below), the Worcester facility will be based on fully disposable equipment. It will boast 4,500 L of bioreactor capacity, made up of two 2,000 L traditional fed-batch and one 500 L perfusion-based continuous processing system.

US Environment

This is the third site to be constructed outside of China, following announcements made over the past month to build a similar clinical and commercial 4,500 L facility in Singapore and a 54,000 L facility in County Louth, Ireland.

According to Chen, the decision to move into the US was based on capacity needs, and not recent changes in the US tax and manufacturing landscape.

“Since we planned this site for more than a year, current trade policy does not play a role in decision making. We will increase our capacity globally based on our needs.”

Internal Expansion Vs Acquisition

Experts in the Chinese biomanufacturing space applauded WuXi’s latest movement.

“It makes sense on their part as it simplifies supply chain for contracts in the US,” Matthew Minakowski

senior business development manager of fellow China-based CDMO Mab-Venture Biopharma told us. “The facility presence in the US also reduces potential hesitance of smaller companies who may not want to go to China for CMC development or CMO work.”

He added China has seen other biopharma moving to the US through acquisition – 3S and Therapure, Hepalink and Cytovance, for example – “but WuXi seems to favor internal expansion over acquisition in areas they have the capability such as manufacture.”

Most Ambitious CMO Service Offerings in Industry History

David Deere, founding chief commercial officer of PaizaBio, commented via social media:

“WuXi has embarked on the most ambitious CMO service offerings in industry history, throwing their spear into the ground on three continents and if successfully executed both operationally and commercially, meeting all regulatory hurdles, will seamlessly allow truly global strategic sourcing to meet any client need.”

Deere’s firm  describes itself as a ‘portal of entry’ for Western pharmaceutical companies seeking to enter China. And speaking with BioProcess Insider, he said WuXi’s expansions represent a “very good strategy.”

He continued: “It will use Singapore and the US facility to attract CTM/launch, for eventual commercial production in both US and Singapore, with an option for the client to transfer manufacture to their larger facilities in China or the EU (Ireland).

“In the case of the US, of course, they can always add additional capacity if client wants strictly US domestic production, likely, should Trade discussions impact API with tariffs.”

WuXi Biologic’s Global Network

  DS Capacity GMP Ready Location Clinical/Commercial
MFG1 5,000 L fed-batch/perfusion 2012 Wuxi, China Commercial
MFG2 28,000 L fed-batch

2,000 L perfusion

2017 Wuxi, China Commercial
MFG3 5,200 L fed-batch 2018 Shanghai, China Clinical
MFG4 10,000 L fed-batch 2019 Wuxi, China Clinical/Commercial
MFG5 60,000 L fed-batch 2020 Wuxi, China Commercial
MFG6 6 x 1,000 L perfusion 2021 Mullagharlin, Ireland Commercial
MFG7 48,000 L fed-batch 2021 Mullagharlin, Ireland Commercial
MFG8 48,000 L fed-batch 2021 Shijiazhuang, China Commercial
MFG9 4,500 L fed-batch/perfusion 2022 Shijiazhuang, China Clinical/Commercial
MFG10 4,500 L fed-batch/perfusion 2022 Singapore Clinical/Commercial
MFG11 4,500 L fed-batch/perfusion 2020 Massachusetts, US Clinical/Commercial