Method Made: The Tech Transfer Edge in Cell & Gene Therapy

If your process relies on the "golden hands" of a specific scientist, you don't have a product, you have a research project. Nicholas Crudele and Arnaud Deladeriere discuss the critical leap from academic science to GMP manufacturing in cell and gene therapy.We cover:What is CMC? (A primer for founders) .Why the "Product is the Process" mindset fails in cell therapy.How to use "process parameters" as dials to control patient variability.Why you should use GMP materials as early as possible.

What exactly is CMC, and why is it the backbone of pharmaceutical quality? In this episode, Nicholas sits down with Jeffrey Seres to break down the complexities of Chemistry, Manufacturing, and Controls for early-stage founder-scientists.From the friction between aggressive VC timelines and operational realities to the future of documentation, we cover the critical gaps in moving from R&D to commercial manufacturing.Topics covered:Defining CMC: The control and oversight governing manufacturing quality.The Strategy Gap: Why rushed timelines destroy CMC strategy and how to mitigate "Time vs. Money" arguments with investors.Board Composition: Why startups need operational expertise, not just bankers and academics, on their boards.The Future of Docs: Why putting paper on an iPad isn't true digitization—and why full process automation is the real goal.

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

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

Beyond the Brochure: Mastering the CDMO Partnership for Successful Tech Transfer with Klaus DörreHow do you choose the right CDMO beyond a slick brochure? And once you do, how do you bridge the critical gap between brilliant R&D and the disciplined realities of GMP manufacturing?In this episode, we're joined by Klaus Dörre, a seasoned professional with deep experience across cell and gene therapy and biologics. Having worked on both the innovator and the CDMO side, Klaus offers a rare 360-degree view of the tech transfer process.We dive into the essential, yet often overlooked, elements of a successful partnership, including the mindset shift required to move from the lab to the plant.In this episode, you will learn:The green flags to look for when selecting a manufacturing partner.Why robust analytics and well-defined potency assays are non-negotiable, even in early phases.The crucial difference between documenting research experiments and writing GMP-ready protocols and SOPs.How to build a relationship based on trust and transparency, turning your CDMO from a simple vendor into a true strategic partner.Key advice for early-stage companies on de-risking their CMC strategy to avoid costly delays.This conversation is a must-listen for founders, CMC leaders, and scientists on the journey from discovery to clinical production. If you are approaching your first tech transfer, see how we can help.