Mitigating Aggregation & Contaminant Risks in Peptide Process Development: Strategies for Enhanced Manufacturing Efficiency and Product Quality
Time: 11:00 am
day: Conference Day Two
Details:
- Focusing on minimizing aggregation during downstream processing and fill & finish operations, while also monitoring physical stress and implementing control measures to prevent aggregation
- Developing and implementing relevant analytical and orthogonal characterization methods to characterize aggregates and particulates
- Monitoring and evaluating Extractables and Leachables (E&Ls) from manufacturing equipment and container-closure systems to minimize potential toxicity and immunogenicity risks associated with genotoxic and carcinogenic substances
