WuXi Biologics
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Locations & Facilities
We are headquartered in Wuxi, China and maintain operations at three locations in Wuxi, Shanghai and Changzhou. These sites are proximately located within a 200-kilometer radius, or approximately a two-hour drive, which ease logistic coordination, simplify program management, and improve project efficiency, thereby working to reduce the overall time and costs of drug development.
We seek to expand our discovery, development and manufacturing capabilities and capacity at the Wuxi site, to encompass the full-spectrum of services for the antibody and payload-linker intermediates and the bioconjugate drug substance and drug product. Our goal is to achieve self-sufficient operations, and establish the necessary manufacturing capacity to meet the needs of multiple late-stage bioconjugate projects. Outside of China, we are planning to establish a manufacturing base in Singapore to meet the growing demand for end-to-end bioconjugate CRDMO services and implement a “global dual sourcing” strategy, which supports continuous and timely provision of services and product supply to our customers around the globe.
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Wuxi, ChinaPrimary Use
Drug Substance/Drug Product
GMP-compliant production
Formulation and analytical development
QC release and stability testing
Capacity
Conjugation Drug Substance (“XBCM”) Production and Antibody Intermediates Production (“XmAb”)
XBCM1 facility with single-use reactor systems ranging from 5 liters to 500 liters and the redesigned reactor system with additional DS capacity which is expected to launch in 2025.
The dual function XmAb/XBCM2 (“XBCM2 Line 1”) facility is designed with capacities ranging from 50 liters to 2,000 liters per batch for monoclonal antibody intermediates or 2,000 liters of drug substance per batch. A second line (“XBCM2 Line 2”), also with dual function design, commenced operation in November 2024.
Conjugation Drug Product Production (“XDP”)
XDP1 facility is designed to produce three million doses of bioconjugates per year in liquid or lyophilized form (3 million vials, lyophilizer 1×5 m2 & 1×20 m2).
XDP2 facility is designed to produce five million doses of bioconjugate drug products per year in liquid or lyophilized form (5 million vials, lyophilizer 1×5 m2 & 2×20 m2).
XDP3 facility is designed to produce seven million doses of bioconjugate drug products per year in liquid or lyophilized form (7 million vials, lyophilizer 2×30 m2) and is expected to commence operation in second quarter of 2025.
XDP5 facility is designed to produce twelve million doses of bioconjugate drug products per year in liquid or lyophilized form (12 million vials, lyophilizer 4x30m2) and is expected to commence operation in 2027.
Payload Linker (“XPLM”)
XPLM1 facility is designed as a kilogram-scale payload and linker production line.
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Singapore(New Expansion Sites)Primary Use
Clinical or commercial manufacturing of antibody intermediates, drug substance and drug product
Capacity
Conjugation Drug Substance Production
Dual function XmAb/XBCM3 facility is designed with capacity to produce 50 liters to 2,000 liters per batch for monoclonal antibody intermediates, or up to 2,000 liters per batch for bioconjugate drug substance and is expected to commence operation by late 2025.
XBCM4 production line facility with capacity of up to 500 liters of bioconjugate drug substance per batch and is expected to commence operation by late 2025.
Conjugation Drug Product Production
The XDP4 facility is designed to produce eight million doses of bioconjugates per year in liquid or lyophilized form with 200 to 300 vials per minute for liquid or lyophilized drug products (8 million vials, lyophilizer 1×10 m2 & 2×30 m2) and is expected to commence operation by mid 2026.
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Shanghai, ChinaPrimary Use
Bioconjugate discovery and process development
Laboratories for bioconjugate discovery and process development.
Bioconjugate discovery, research and process developmentAnalytical and formulation development
Scale-up conjugation
Capacity
Discovery lab
Laboratories for bioconjugate discovery and process development.
Bioconjugate process development lab
Bioconjugate process development and analytical method development. Laboratory-scale sample preparation to pilot-scale manufacturing of ADCs and other bioconjugates.
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Changzhou, ChinaPrimary Use
Payload-linker
Discovery, research and process and analytical development
Pilot-scale synthesis
GMP-compliant production
Capacity
Payload-linker
Laboratory with a field-tested containment design to safely handle highly potent compounds that are designated as OEB (occupational exposure band) 5-rated materials.
Equipped with reaction kettles for GMP-compliant production with capacity of up to 150 liters per batch, enabling the Group to produce payloads and linkers at a kilogram scale.
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