Fucheng Biopharmaceutical (Zhejiang) Co., LTD. (hereinafter referred to as "Fucheng Bio") is an international CDMO enterprise focusing on the process development and scale production of biological macromolecule drugs, and providing professional and efficient services to global customers with a leading technology platform。Fucheng Biology has a CMC technology platform for all stages of the complete research and development cycle of biomacromolecule drugs,Experience in production and registration,Can undertake overseas License-in project domestic mass production and domestic antibody drug project clinical to commercial stage of the sea service,And customized commercial production for strategic partners。
Learn moreFull stage management of commercialization
Integrated quality management
Verification system
CN/US/EU cGMP
QMS/SAP/LIMS system
Manage all stages from DNA to commercialization
Cell line development
Cell culture process development
Purification process development
Formulation development
Process characterization, process verification
Perfect process and preparation development platform
Physical, chemical and biochemical analysis
Cell biological analysis
Protein characterization
Activity study
Fraction collection and identification
HCP antibody coverage verification
All-round analysis method development, biochemical analysis method development and identification characterization platform
cGMP cell bank
Stock solution production
Preparation production
Full life cycle technology transfer
Provide better differentiated biomacromolecule CDMO services, more controllable drug delivery costs and a faster results conversion platform
Validation of analytical method
Batch release detection
Stability study
Material inspection
Environmental monitoring
Process impurity removal verification
Build a whole-chain quality management system in line with domestic and international standards
采购
仓储
物流
Label, Packaging
Supply chain operation of bulk liquid and preparation production
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