Leveraging Host Cell Protein Detection and Quantification to Support Process Development and Risk Mitigation for Gene Therapy
Time: 12:00 pm
day: Track A Day 2
- Gene therapy manufacturing for clinical supply must ensure robust and consistent production of safe and efficacious products.
- Removal of product- or process-related variants or impurities is required to meet the pre-determined specifications.
- The ability to detect and identify residual impurities including host cell proteins is essential for risk assessment and mitigation.
- Readily available immunoassays combined with advanced applications of orthogonal methods provide tools to support process development and quality control.