Viral Vector Process Development

Viral Vector Process Development Services

Pharmaron’s gene therapy team provides world-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 deep technical knowledge is allied with 20 years+ of regulatory and drug development experience to ensure we begin vector development with a successful end in mind. This, coupled with our viral vector manufacturing platform and our plasmid capabilities, means we are a one stop shop for vector production by transfection.

Upstream Development & Optimization

  • Cell line development, with protocol design options to suit client needs, using flexible high throughput automated capabilities
  • Production and storage of research and GMP cell banks for mammalian, microbial and insect cell lines
  • Cell culture and transfection development
  • A scalable, suspension-based platform processes with bioreactor scales from 15mL to 50L in development

Downstream Viral Purification Development

  • Chromatography-based purification
  • Ultra-centrifugation available
  • Flexible toolbox approach for multi-serotype purification
  • High throughput purification development using advanced robotics
  • Scaled down process assessment through automated approaches
examining media in AMBR

Process Characterization and Validation

  • Late-stage product development experience to define Critical Quality Attributes (CQAs) based upon FDA, EMA and ICH guidance
  • Strong experience across process design, process qualification and establishing Continued Process Verification across a range of biologics
  • Targeted risk-based approach to process characterization and validation to define Critical Process Parameters (CPPs)
  • Generation of analytical and process control strategies ready for Process Performance Qualification (PPQ)
  • Experience in PPQ execution, pre-approval inspection and regulatory dossier authoring

Download poster to learn more about Pharmaron’s toolbox approach for adaptive multi-serotype AAV solutions.