Pieter Swanepoel

With the rise of complexity in mRNA modalities as an application or tool, now better innovations and approaches are now required to ensure scalable manufacturing and CMC process towards the clinic. This workshop will dive into new CMC and regulatory pathways to go from drug substance to final product with new processes, strategies, and manufacturing insights across the Asia-Pacific Region.

Join this discussion to gain key insights on:

• From Lab to GMP: Practical strategies for accelerating mRNA process development, quality control and regulatory alignment – Insights from Australia’s end-to-end RNA ecosystem
• CMC and regulatory strategies for self-amplifying mRNA vaccine manufacturing in Japan
• Technical process development and CMC scale-up strategies – Real-world approaches to accelerating mRNA manufacturing while maintaining quality and analytics robustness for domestic production