GMP Manufacture and QP Release
GMP Manufacturing and QP Release Services
Pharmaron’s Gene Therapy CDMO, located in Liverpool, UK, leverages its industry-leading expertise in process R&D, cGMP manufacturing and advanced analytical capabilities to support our partners in the development and manufacture of gene therapy products.
Our world-class, cGMP manufacturing facility is purpose-designed for viral vector manufacture. We have expertly trained cGMP staff consistently delivering drug substance to high quality standards with our ‘right first time’ approach.
Capabilities
GMP Manufacture
- 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
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
