The $1M CDMO Selection Trap & Rethinking CMC Roadmaps with Shri Joshi
From Out of the Lab Podcast · 00:40:11
Show by Out of the Lab Media Group
Why does selecting the cheapest CDMO quote often lead to millions of dollars in unexpected costs down the road?In this episode of Out of the Lab, host Nico sits down with industry veteran Shri Joshi, who has navigated cell and gene therapy operations across consulting, CDMO, and sponsor sides to break down the core ingredients of a successful drug development lifecycle.We explore why CDMO selection must be treated as a development and risk-management decision rather than a simple procurement task. Shri breaks down why early investments in analytical methods create crucial operational flexibility, why the adage "the process is the product" can actually harm development, and how early-stage founders can build a true "comparability mindset" to de-risk clinical progression.Key Topics Covered:00:01:34 – The 3 core ingredients of cell & gene therapy development00:04:20 – Why CDMO selection is a risk management decision, not procurement00:07:28 – Case Study: Transparency vs. unrealistic timeline promises00:18:38 – The real cost of cheap contracts: How a $1M discount cost $5M later00:21:41 – CMC 101: Chemistry, Manufacturing, & Controls explained00:24:37 – Why "the process is the product" dogma creates operational bottlenecks00:27:53 – Developing analytical methods early to enable comparability00:32:04 – Utilizing Quality Target Product Profiles (QTPP) & Process Flow DiagramsThis episode is brought to you by Method Made. Accelerate your tech transfer by up to six months using video SOPs to capture technical nuance. Download the free Tech Transfer Failure Modes and Effects Analysis at methodmade.ca by clicking Download FMEA.
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