Gene Therapy CDMO

doctor in scrubs working

Pharmaron’s team provides gene therapy development services from our state-of-the-art cGMP biomanufacturing facility in Liverpool, UK, which includes advanced analytical platforms, high-throughput process development equipment and purpose-designed viral and plasmid GMP manufacturing suites.

Scientists in full protective gear operate advanced bioreactor systems for GMP and research-grade plasmid manufacturing in a cleanroom facility.
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
A scientist in protective gear prepares a syringe while working with a wave bioreactor, focusing on viral vector process development.
Our Services

Viral Vector Process Development and GMP Manufacturing

  • Upstream development & optimization
  • Downstream Viral Purification Development
  • Process Characterization and Validation
A scientist conducts product characterization and quality control (QC) analysis in a lab, working with a flow cytometer. The data on the screen displays detailed graphs and peaks, indicating an analysis of biological or pharmaceutical samples for purity, potency, and safety.
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
Scientists in cleanroom suits monitor bioreactors and process control systems for GMP manufacturing and QP release of pharmaceutical products.
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
A group of professionals participates in a regulatory dossier authoring meeting. The lead speaker addresses the team, surrounded by notebooks and documents, as they discuss compliance and documentation for regulatory submissions. A large screen and conference phone suggest a collaborative and formal setting.
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