We provide a variety of conjugation manufacturing services for antibody drug conjugates (ADCs) and other bioconjugates including cytotoxin-linker solution preparation, conjugation, purification and bulk filling. The conjugation lines are equipped with state-of-the-art equipment which include single-use reactor systems ranging from 5 L to 500 L, filtration and chromatography purification technologies, high-accuracy and flexible temperature control units, and well-developed and advanced rapid cooling systems for heat sensitive and labile products. In addition, all consumables used in the conjugation process are single use (including glass reactors).
The WuXi XDC GMP facility (DP3) is located in the Xinwu District, Wuxi, Jiangsu, China. The site is dedicated to ADC / bioconjugate drug development and manufacturing. The company holds a Drug Manufacturing License issued by the China NMPA and the site meets U.S. FDA and EMA GMP regulations and EHS requirements.

Beyond drug substance (DS) GMP manufacturing, the site provides customized one-stop services to support everything from development to clinical and commercial supply. This single-source platform greatly increases the efficiency of ADC / bioconjugate development and production. Capabilities at the site includes:
The functional areas include conjugation, compounding, filling, lyophilization, QC laboratory, warehouse, and engineering utilities. The annual DS conjugation batch capacity is over 100 batches and WuXi XDC is expanding large-scale manufacturing capacity and adding automatic packaging capabilities in the future to meet the commercial supply demands of current and future clients.
At WuXi XDC, the conjugation manufacturing process for ADC/bioconjugate drug substance starts with payload-linker dispensing and consists of the conjugation reaction, purification and bulk filling. There are two dispensing cabinets for weighing and dissolving highly-potent compounds, which include a stainless steel negative pressure isolator and a single-use plastic isolator.
See the table below for manufacturing capacities across the entire ADC/bioconjugate supply chain.
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mAb
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Payload-Linker
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ADC Drug Substance (DS)
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ADC Drug Product (DP)
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Lab scale
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√
|
√
|
√
|
√
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Non-GMP pilot scale
|
√
|
√
|
√
|
√
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cGMP manufacturing
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> 2 kg
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> 5 kg
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Up to 5 kg
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2~50 ml vials (up to 18,000 vials/6 hour run [2R vial])
5 ㎡ and 20 ㎡ lyophilizer
(up to ~85,000 vials/batch/day [2R vial])
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