Understanding the Impact of Peptide Polymorphism on Downstream Process Development
Time: 9:45 am
day: Conference Day Two
Details:
- Exploring the diverse structural forms of peptides and how variations in conformational states can influence critical quality attributes (CQAs) and downstream processing parameters
- Discussing the challenges associated with polymorphism in peptide purification and proposing strategies to mitigate risks and ensure consistent product quality
- Addressing the regulatory implications of peptide polymorphism on drug development, emphasizing the importance of robust control strategies, analytical methodologies, and risk assessment frameworks to ensure product safety, efficacy, and compliance
