WuXi XDC Launches New Commercial Manufacturing Facilities

New commercial facilities offer one-stop manufacturing services for antibody intermediates,bioconjugate drug substance and drug product

Doubled capacity provides greater support to the rapidly growing globalbioconjugate industry

WUXI,China,Sept. 20,2023 -- WuXi XDC,a leading global Contract,Research,Development and Manufacturing Organization (CRDMO) for ADCs and other bioconjugates,today announced that its new commercial manufacturing facilities (known as XBCM2 and XDP2) in Wuxi,Jiangsu Province,have been released for GMP manufacturing. This will further enable clients to accelerate their pipelines' commercial production in the fast-growing bioconjugate industry.

WuXi XDC's new GMP manufacturing facilities cover an area of nearly 7,000 square meters,comprising the dual-function production line XBCM2,for bioconjugate drug substance and antibody intermediates production; the XDP2 facility,for bioconjugate drug production; as well as testing and commercial packaging spaces. The two facilities feature automated systems and state-of-the-art equipment,and provide comprehensive one-stop GMP manufacturing services for ADCs and other bioconjugates at both the clinical and commercial stages. The capacity expansion is designed to meet the increasing demand from the global bioconjugate industry,and underlines WuXi XDC's commitment to being a trusted partner for clients worldwide.

The dual-function GMP manufacturing facility XBCM2 offers end-to-end manufacturing services – from monoclonal antibody intermediates to ADC drug substance. The facility can provide production for monoclonal antibody intermediates on a scale of 200 liters to 2,000 liters per batch,for upstream cell culture and downstream protein purification,while two independent ADC drug substance production lines are able to meet the demand for ADC drug substance manufacturing up to 2,000 liters.

The bioconjugate drug product GMP manufacturing facility XDP2 features advanced isolator aseptic filling technology and a single-use filling system that is equipped with on-line 100% drug weighing and a complete product testing function. It provides complete production capacity for highly potent and aseptic products and offers a fully automated commercial packaging capability. With the ability to produce liquid and lyophilized formulations in sizes from 2R to 50R,it reaches an annual production capacity of 5 million vials.

Dr. Jimmy Li,CEO of WuXi XDC,commented,"The growing demand for the development and commercialization of ADCs and other bioconjugates provides us with great growth opportunities. The new facilities further expand our capacity and bolster our comprehensive one-stop GMP capability,providing stronger support to meet our clients' demands in development and manufacturing. Meanwhile,our Singapore manufacturing facility is under design,which will further expand our capacity and enhance WuXi XDC's global presence. With the extensive experience and expertise we have accumulated over the past decade,we aspire to empower the industry to accelerate the pace of bioconjugate innovation,and enable our clients to bring new treatment solutions for patients worldwide."

About WuXi XDC

WuXi XDC is a leading global CRDMO focused on the ADC and broader bioconjugate market. It is a joint venture between WuXi Biologics and WuXi STA,providing end-to-end contract research,development and manufacturing services for bioconjugates,including antibody drug conjugates (ADCs). Its services cover antibody intermediates and other biologics intermediates,chemical payloads and linkers,as well as bioconjugate drug substances and drug products. WuXi XDC has been successful in bringing multiple ADC projects to the Investigational New Drug (IND) filing stage in 15 months or less,nearly cutting in half the traditional development timeline. As of June 2023,110 ongoing integrated projects are under development at WuXi XDC,including 47 post-IND bioconjugate projects,among which 16 projects are in phase II/III. For more information about WuXi XDC,please visit:www.wuxixdc.com

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