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GMP偶联生产

The conjugation manufacturing process for ADC/bioconjugate drug substance

偶联生产从细胞毒素-连接子的配制开始,包括偶联反应、纯化和原液分装。有两种用于称量和溶解高毒性化合物的配制柜,一种为不锈钢负压隔离器,一种为一次性塑料隔离器。

 

偶联车间生产能力见下表:


 
单抗或其他大分子
细胞毒素-连接子
生物偶联药物
实验室规模
Non-GMP 中试规模
cGMP 生产
 > 2 kg
> 5 kg
Up to 5 kg

 


  • 核心设备

 

    • OEB5级的隔离器
    • 多台10-1,000升一次性混匀设备。
    • 5 – 500升等多种规格偶联生物一次性反应器(一次性玻璃反应器,一次性塑料反应器)。
    • 蛋白纯化仪,超滤浓缩,器具清洗机和灭菌柜等辅助的清洗、灭菌设备。


  • 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