Viral Vector Process Development
Viral Vector Process Development Services
Pharmaron’s gene therapy team provides world-leading expertise in viral vector process development, cGMP manufacturing, and advanced analytical capabilities to accelerate your gene therapy viral vector manufacturing programs.?
Our deep technical knowledge is allied with more than 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 plasmid capabilities, means we are a one-stop shop for vector production by transfection.
Upstream Process Development & Optimization
- Custom upstream process development including cell line development and protocol design tailored to client requirements
- 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 characterization and validation,, including design, qualification, and 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.
