CN
2025-03-03 13:54
Spotlight: AsymBio Launched Shanghai Fengxian Facility
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AsymBio, the subsidiary of Asymchem Laboratories (Stock Code: 002821.SZ/6821.HK), announced the official inauguration of its CDMO base in Fengxian, Shanghai. This facility will provide late-stage clinical and commercial manufacturing services for antibodies and bioconjugates.


Spanning over 120,000 square meters, the Fengxian Facility is designed to meet growing global demand for innovative biologics. The Phase IA facility now operational features: 


- Antibody Drug Substance (DS): 2,000L single-use bioreactors and purification lines. 


- Antibody Drug Product (DP): B+A grade fill-finish lines with ORABS and 20 m² lyophilizer, supporting 2R-20R vials.


Phase IB, set for completion by late 2025, will add ADC DS and DP workshops. Future phases will integrate QC labs, R&D centers, and operational hubs to enhance AsymBio's one-stop service ecosystem. 


The Fengxian Facility complements AsymBio's existing Jinshan facility, which offers GMP-compliant antibody and ADC production capacities including: 


- Antibody DS at 200L/500L/2000L scales. 


- ADC DS production at 100L/200L/500L scales.


- Fully isolated automated filling lines and lyophilizers (5 m²-10 m²), enabling 6R-20R vial services. 


The company's quality system adheres to NMPA, FDA, EMA, and ICH guidelines, with successful EU QP audits and MNC client inspections. Its project management expertise spans clinical strategy to multi-module execution, ensuring agile support for partners worldwide. 


AsymBio currently supports 21 out of 27 Chinese biopharma companies in ADC licensing-out projects, cementing its role as a critical partner in the bioconjugate supply chain. 


AsymBio aims to empower global innovators with integrated and reliable CDMO solutions.


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