Gene Therapy CDMO
康龙化成英国利物浦团队拥有最先进的cGMP生物药生产设施，包括先进的分析平台，高通量的工艺开发设备，以及专门设计的病毒和质粒GMP生产车间，为客户提供基因治疗产品的开发服务。
研发能力
Our Services
Plasmid DNA Process Development and GMP Manufacturing
- GMP and research grade plasmid manufacture
- E. Coli cell banking
- GMP release and stability testing for cell banks and plasmids
Our Services
Viral Vector Process Development and GMP Manufacturing
- Upstream development & optimization
- Downstream Viral Purification Development
- Process Characterization and Validation
Our Services
Product Characterization and QC Analytics
- Product Characterization
- Analytical Method Development
- Cell-based Bioassays and Molecular Biology
- GMP Testing
- Stability and Forced Degradation Studies
Our Services
GMP Manufacture and QP Release
- Starting material production, management and release
- Phase-appropriate method validation and method transfer
- Advanced analytical toolkit for process & product characterization
- Qualified and/or validated in-process monitoring and release testing for GMP release
- Effective scale-up and technical transfer to one of our GMP viral vector suites
Our Services
Regulatory Dossier Authoring and Specification Justification
- Assembly of Quality CTD sections, dossier ready documentation and inspection readiness
- Phase appropriate CMC development planning
- Orphan drug designation experience
- Attendance at health authority meetings and regulatory audits
