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GMP Conjugation Manufacturing

Bioconjugation GMP manufacturing for ADC/bioconjugate drug substance

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:

 

  • Technology transfer
  • Pilot scale and GMP conjugation DS production
  • Formulation development (both frozen liquid and lyophilized dosage forms)
  • Drug product (DP) process development
  • GMP drug product manufacturing

 

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.

 
mAb
Payload-Linker
ADC Drug Substance (DS)
ADC Drug Product (DP)
Lab scale
Non-GMP pilot scale
cGMP manufacturing
 > 2 kg
> 5 kg
Up to 5 kg

2~50 ml vials (up to 100,000 vials/batch/day [2R vial])

5 ㎡ and 20 ㎡ lyophilizer

(up to 25,000 vials/batch/day [2R vial])

  • Key equipment

 

    • OEB5 isolator for payload-linker dispensing and dissolution
    • Mixing tanks (10 L, 50 L, 100 L, 200 L, 500 L, and 1,000 L)
    • Single-use glass or plastic bioreactors, (5 L, 15 L, 30 L, 50 L, 100 L, 200 L and 500 L)
    • AKTA Ready, UF/DF system
    • Auxiliary equipment such as parts washer and autoclave

For more information on the site’s capabilities and capacities – click here


 


  • In addition to ADC/bioconjugate drug substance and drug product GMP manufacturing, WuXi XDC’s single-source bioconjugate platform includes non-GMP and GMP manufacture of all intermediates including the mAb/protein, payload and linkers.

  • All of our manufacturing operations are overseen by our comprehensive global Quality System that has been audited by multiple regulatory agencies including the FDA, EMA, NMPA, PMDA, MFDS, HSA, ANIVSA, HPRA and Health Canada.

For more information