Foster Biologics (the company) is an international CDMO enterprise focusing on process development and scale manufacturing of Biologics, with core customers and continuous innovation capabilities. The company has a CMC technology platform with full biologic life cycle products development, manufacturing and regulatory experience, can undertake License-in projects from US and EU by domestic scale manufacturing overseas services from clinical to commercialization for domestic antibody drug projects, and offer its strategic partners tailor-made commercial manufacturing.
MOREFrom DNA to Commercial Manufacturing
Comprehensive Quality
Validation System
CN/US/EU cGMP
QMS/SAP/LIMS
from DNA to Commercial Manufacturing
Cell Line Development
Cell Culture Development
Purification Development
Formulation Development
Process Characterization and Validation
Comprehensive Process and Formulation Development Platform
Physicochemical and Biochemical Assays
Biological Assays
Product Characterization
Enrichment And Fractionation of Minor Product Variants for Characterization
HCP Antibody Coverage Analysis
Full-functional Analytical Development and Product Characterization Platform
Analytical Method Validation
DS & DP Release
Stability Studies
Material Testing
Environmental Monitoring
Process-related Residual & Product-related Impurity Testing
Build a full-chain quality management system that meets domestic and international standards
Procurement,
Warehousing
Logistics
Labeling & Packaging
DS and DP MFG supply chain operation
cGMP Cell Banking
DS MFG
DP MFG
Provide better differentiated biomacromolecule CDMO services, more controllable drug supply costs and faster results transformation platform
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