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GMP Conjugation Manufacturing

The conjugation manufacturing process for ADC/bioconjugate drug substance

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.

 
mAb
Payload-Linker
ADC
Lab scale
Non-GMP pilot scale
cGMP manufacturing
 > 2 kg
> 5 kg
Up to 5 kg

  • 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


  • Bioconjugation is conducted at our Drug Product manufacturing facility (DP3) located in Wuxi, China.  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.

For more information