Biogenic organism

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。

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CDMO one-stop service

Full stage management of commercialization
Integrated quality management
Verification system
CN/US/EU cGMP
QMS/SAP/LIMS system

Manage all stages from DNA to commercialization

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Technology science

Cell line development
Cell culture process development
Purification process development
Formulation development
Process characterization, process verification

Perfect process and preparation development platform

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Analysis and formulation science

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

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GMP production

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

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Quality control

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

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Supply chain system

采购
仓储
物流
Label, Packaging

Supply chain operation of bulk liquid and preparation production

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Service consulting

Service consulting

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