Are you an R&D-focused founder who thinks of manufacturing as a problem for "later"? This episode is a critical wake-up call.

CMC expert and Managing Director David Bruehlmann joins the podcast to explain why a staggering number of promising therapies fail due to CMC issues and how treating "details" as an afterthought can lead to catastrophic failures.

We dive into the story of a real-world tech transfer that failed, not because of the equipment, but because of a single, un-documented variable: the light exposure in the lab.

This conversation is essential listening for any scientist, engineer, or founder preparing to scale their process.

In this episode, you will learn:

• What CMC Strategy Is: Why it's not an "afterthought" but a strategic asset that must be built from day one.

  
  

• The "Quality by Design" Mindset: How to work backward from the patient to define your critical process parameters and control strategy.

  
  

• How to Choose a CDMO: Why the right partner is about cultural fit, size, and experience—not just the lowest cost.

  
  

• Why CGT is Harder: The fundamental difference between biologics ("the process is the product") and cell therapy ("the cell is the product").

  
  

• The R&D vs. Engineering Mindset: The critical (and necessary) culture clash between scientists focused on results and engineers focused on robustness.

  
  

  If you would like to suggest future episode topics and/or guests, get in touch on LinkedIn