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 production
Conjugation drug substance production line (“XBCM1”) with single-use reactor systems ranging from five liters to 500 liters to produce up to 500 liters of conjugation drug substance.
The dual-function GMP manufacturing facility XBCM2 offers end-to-end manufacturing services – from monoclonal antibody intermediates to ADC drug substance- meeting the demand for ADC drug substance manufacturing up to 2,000 liters.
Conjugation drug product production
The conjugation drug product (“XDP1”) facility is designed to produce the liquid and lyophilization dosage forms with the annual capacity of up to three million vials in an isolated filling line equipped with one 5 sq.m. lyophilizer and one 20 sq.m. lyophilizer.
The bioconjugate drug product GMP manufacturing facility XDP2 provides complete production capacity for highly potent and aseptic products. 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.
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Singapore(New Expansion Sites)Primary Use
Clinical or commercial manufacturing of antibody intermediates, drug substance and drug product
Capacity
Antibody intermediates and drug substance production
Dual-function XmAb/XBCM3 production line with capacity of producing 200 liters to 2,000 liters per batch for monoclonal antibody intermediates and up to 2,000 liters per batch of bioconjugate drug substance
XBCM4 production line with capacity of up to 500 liters of bioconjugate drug substance per batch
Conjugation drug product production
Two drug product manufacturing lines with annual capacities of up to eight million vials and three million vials, respectively
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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
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 OEB5-rated materials.
Equipped with reaction kettles for GMP-compliant production with capacity of up to 150 liters, enabling kilogram-scale production of payload-linkers.
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