WuXi Biologics achieves large-scale manufacturing milestone

A combination of four 4,000-litre single-use bioreactors reaching a 16,000-litre scale has resulted in the successful completion of WuXi Biologics’ first manufacturing run at its drug substance facility MFG7 in Ireland. 

This is the largest manufacturing scale for the contract research, development and manufacturing organisation’s (CRDMO) to date.

The company shared that the Cost of Goods (COGS) from this run is comparable to that of a 16,000-litre traditional stainless-steel bioreactor.

According to WuXi Biologics, this reinforces the comparable cost observed in more than 100 runs at 12,000-litre scale single-use bioreactors.

When compared with a traditional 12,000-litre stainless steel bioreactor, this is 6×2,000-litre in the MFG2 and MFG5 facilities and 3×4,000-litre in the MFG5 and MFG8 facilities.

This inaugural run sets the stage for large-scale commercial manufacturing projects at this facility, Wuxi Biologics explained.

Prioritising sustainability and clean energy

As a good manufacturing practice (GMP)-certified facility, its first GMP certificate was achieved just nine months after operations began, the CRDMO confirmed.

Additionally, in December 2023, the Ireland site also obtained ISO 50001 (Energy Management), ISO 14001 (Environmental Management System), and ISO 45001 (Occupational Health and Safety Management System) certifications, Wuxi Biologics added.

“We are excited to achieve this milestone for the Ireland facility. Once again it demonstrates that comparable COGS can be achieved by leveraging more environmental social governance (ESG) friendly single-use technologies,” Dr Chris Chen, CEO of WuXi Biologics explained.

Building on earlier manufacturing developments

This news follows the company’s announcement in September last year, which detailed that had launched new commercial manufacturing facilities in Wuxi, China. These were designed to support production of bioconjugate drug substances and drug products. At the time of the launch, Wuxi Biologics highlighted that that features within the expanded capabilities include automated systems and GMP manufacturing services.

As an organisation with facilities that utilise next-generation biomanufacturing technologies, Wuxi Biologics affirmed during a statement on its proposed spin-off in July 2023, that the transition would facilitate “faster, innovative development and manufacturing of biologics”.

With the notable manufacturing run at its Ireland facility a success, this paves the way for continued manufacturing innovation.