Abhi Kavathia
Associate Director CMC BioNTech
Seminars
Wednesday 23rd September 2026
Building a Phase-Appropriate CMC and QbD Strategy for mRNA-LNP Development
3:00 pm
- Define CQAs, CMAs, and CPPs to establish a robust Quality by Design framework from early development through clinical manufacturing
- Create process–product relationships that support scale-up, technology transfer, and consistent product quality
- Develop analytical and control strategies that evolve with program maturity and meet regulatory expectations
- Apply risk-based CMC decision making to accelerate development timelines while maintaining product quality and compliance
