GMP Gene Therapy Manufacturing and QP Release
GMP Gene Therapy Manufacturing and QP Release Services
Pharmaron’s Cell and Gene Therapy CDMO (CGT CDMO), located in Liverpool, UK, leverages its industry-leading expertise in process R&D, cGMP manufacturing, and advanced analytical capabilities to support to support our partners across every stage of gene therapy manufacturing.
Our world-class cGMP manufacturing facility is purpose-designed for viral vector manufacture. We have expertly trained cGMP staff to consistently deliver drug substances to high-quality standards with our ‘right-first-time’ approach.
Capabilities
GMP Gene Therapy Manufacturing
- Up to 500L scale bioreactors
- Suspension-based cell culture
- Chromatography-based purification solutions
- Purpose-built manufacturing facility
- State-of-the-art manufacturing scale-validated equipment
- Flexible and independent manufacturing suites
- cGMP controlled warehouse
- cGMP-controlled cell bank storage facility
CGT CDMO Services
- 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
- Rapid transition from development to clinical manufacture, utilizing Pharmaron’s established platform processes and multi-skilled process sciences team
- cGMP controlled storage of cell banks, raw materials and consumables
- Effective scale-up and technical transfer to one of our GMP viral vector suites
