The Hidden Bottleneck in Clinical Trials: GMP Manufacturing for RNA and Advanced Therapies
Date: Thursday, 12 March 2026
Time: 11:35 AM (Day 2)
Title: The Hidden Bottleneck in Clinical Trials: GMP Manufacturing for RNA and Advanced Therapies
- As RNA and other advanced therapies move rapidly from discovery into the clinic, many programmes encounter an unexpected bottleneck: access to suitable GMP manufacturing
- Delays that impact trial timelines and costs, driven by limited capacity, specialised process requirements, and evolving regulatory expectations
- How early CMC and manufacturing strategy can de-risk clinical development for RNA, mRNA, pDNA, and other advanced therapeutics
- Aurora’s experience in advanced GMP manufacturing, including common challenges, practical approaches to securing clinical supply, and how sponsors can design programmes that are both trial-ready and scalable for later phases