New manufacturing facilities to enhance bioconjugate industry

WuXi XDC’s new commercial manufacturing facilities in Wuxi, China have been released for good manufacturing practice (GMP) manufacturing. The contract, research, development and manufacturing organization’s (CRDMO) XBCM2 and XDP2 facilities cover an area of nearly 7,000m². Dual-function production line XBCM2 is designed for bioconjugate drug substance and biologic antibody intermediates production. The XDP2 facility is intended for bioconjugate drug production, as well as testing and commercial packaging spaces.

This capacity expansion is designed to meet the increasing demand from the global bioconjugate industry. Features within the two facilities included automated systems, offering one-stop GMP manufacturing services for ADCs and other bioconjugates at both the clinical and commercial stages.

The XBCM2 facility can provide production for monoclonal antibody intermediates on a scale of 200 litres to 2,000 litres per batch, for upstream cell culture and downstream protein purification. Two independent ADC drug substance production lines can meet demand for ADC drug substance manufacturing up to 2,000 litres.

On the other hand, the bioconjugate drug product manufacturing facility XDP2 features advanced isolator aseptic filling technology and a single-use filling system. The building is equipped with on-line 100 percent drug weighing and a complete product testing function. This allows for complete production capacity for highly potent and aseptic products plus a fully automated commercial packaging capability. It has ability to produce liquid and lyophilised formulations in sizes from 2R to 50R, therefore reaching an annual production capacity of five million vials.

“The growing demand for the development and commercialisation of ADCs and other bioconjugates provides us with great growth opportunities. The new facilities further expand our capacity and bolster our one-stop GMP capability,” stated Dr Jimmy Li, CEO of WuXi XDC.

Advancing bioconjugate development

In July 2023, WuXi Biologics announced a proposed spin-off the CRDMO WuXi XDC, to support its bioconjugate development and better capture the fast-growing global bioconjugate market. Thus the new manufacturing facilities in Wuxi, China are set to serve this endeavour.