Spotlight session: Novel modalities for commercial scale up in advanced therapies

As advanced therapies diversify beyond established platforms, developers face the challenge of scaling novel modalities for commercial viability. This session explores approaches to streamline manufacturing, ensure product quality, and align development with regulatory and market expectations for long-term success. 

Key takeaways: 

• Examine scaling considerations unique to emerging therapeutic modalities 

• Identify strategies to adapt manufacturing infrastructure for novel products 

• Discuss translational and commercial challenges in bringing new platforms to scale 

• Evaluate regulatory and CMC implications for scaling non-traditional modalities 

• Explore opportunities to integrate innovation with sustainable large-scale production