cGMP Manufacturing
cGMP manufacturing for biologics, run under one quality system from cell bank to drug product. Our purpose-built 45,000 m² Lingang campus operates nine 2000L single-use bioreactors with fed-batch and perfusion capability, so process knowledge travels with your molecule instead of restarting at each stage.
cGMP Manufacturing
赞助商在评估生物制剂CMC外包合作伙伴时需要了解的一切——从产能到合规性。
Our Facility
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- 67,000 m2
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- Strategically located in Qidong, Jiangsu
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- 45 minutes from the Shanghai Free Trade Zone
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- 50 minutes from the Shanghai Pudong International Airport
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- 1.5 hours from ChemPartner’s Zhangjiang Site
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Phase I mAb Production Plant
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- 13,000 m2
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- Meet mAb production demands for clients globally during clinical phase III and commercial launch periods
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- Flexible to accommodate GMP production for various pre-clinical and clinical stages
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- Comply with ICH guidelines and the highest standards of NMPA and FDA
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- 2x2000L manufacturing line is ready in use
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- Designed for up to 9x2000L SUB for DS production
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- Flexible for different set-ups to meet various needs
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- 2-20mL vial aseptic DP filling and 2×15.4m2 freeze-drying capacity
Cell Culture Production
Purification Production
Filling and Freeze-Drying Production
