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.
Capabilities
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
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.
