The Valley of Death – Overcoming CMC Challenges in the Development of Novel Biotherapeutics

Bridging the gap between research and clinical development is one of the biggest challenges in bringing novel biotherapeutics to market. While biotech start-ups often focus on scientific proof of concept, the complexities of Chemistry, Manufacturing, and Controls (CMC) can be underestimated – leading to delays, inefficiencies, or even failure. Developing a scalable, high-quality but phase appropriate manufacturing process early is critical to ensuring a smooth transition to clinical trials.

In this seminar, we will explore key CMC – related risks in early development and discuss proactive strategies to mitigate them. Learn how Quality by Design (QbD) principles can streamline process development, enhance scalability, and reduce regulatory risks – helping to navigate the ‘Valley of Death’ with confidence.

Speaker: Dr. Matthias Müllner, CEO & Co-Founder of bespark.bio