
Imagine your cell therapy is nearing Phase 3, but a multi-million dollar manufacturing run fails. The reason? A critical, undocumented step from your pre-clinical R&D was lost in translation years ago. This isn't a scientific failure; it's a business failure, and the seeds are often planted long before you scale. Your company's most valuable asset: the unwritten expertise of your scientists, could be the very thing that puts your clinical success at risk.
In this episode, we talk with Akshay Ravindranath, a manufacturing science and technology (MSAT) specialist with 10 years of frontline experience navigating the treacherous gap between R&D innovation and GMP execution. He reveals how seemingly minor details in the lab become major sources of technical risk. These risks lead to delays, and budget overruns during late-stage clinical manufacturing.
For CEOs and CTOs, this conversation is not just about documentation, it's about strategic foresight. Listen to this episode to understand how to identify and secure your most critical intellectual assets now to de-risk your journey to Phase 3 and protect your company's valuation.Looking for a documentation solution to derisk before manufacturing? Drop us a line