Research Grade, High Quality and GMP Plasmid DNA Manufacturing
Research Grade, High Quality and GMP Plasmid DNA Manufacturing
Through leveraging Pharmaron’s proprietary gene therapy plasmid design and technology and in-house manufacturing capabilities, partners can simplify supply chains and take control over both the CMC development for their product and critical plasmid supply.
Pharmaron’s Gene Therapy platform process is underpinned by expert scientific and regulatory knowledge and our focus on quality allows our team to seamlessly deliver research, high quality and GMP-grade plasmids to meet customer timelines.
Capabilities
GMP and Research Grade Plasmid Manufacture
- Access to Pharmaron’s Rep-Cap and Helper plasmids
- Plasmid design and optimization
- Plasmid-specific optimization through targeted process development services
- Animal component free flexible platform production strategies to meet client needs
E. coli Cell Banking
- Production of research grade E.coli cell banks
- Production of GMP E.coli cell master and working cell banks
GMP Release and Stability Testing for Cell Banks and Plasmids
- Grade appropriate documentation and release testing
- Manufacture and testing of research grade non-GMP plasmids
- GMP manufacture of purified bulk plasmid, including testing and batch release
Capabilities
- Range of fermenter scales (250mL to 300L)
- High copy number plasmid production
- Single-use development technologies
- Chromatography-based purification
- Integrated analytical testing
- Product characterization
- Expertise in creation of critical starting materials
- Dedicated microbial GMP processing suites
