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.

From Data to Scale: How Workplace Silos Break Bioprocessing ModelsIn this episode of Method Made, host Nicholas Crudele sits down with digital bioprocessing expert Dr. Moritz von Stosch to uncover why even the most sophisticated bioprocessing models fail when workplace silos disconnect the people who run experiments from those who analyze the data.What You'll Learn:Why analytical variations of 10-20% still plague new modalities in cell and gene therapyHow separation between operators, sample analyzers, and modelers introduces dangerous assumptionsWhy standardization gaps across sites and raw material lots sabotage process developmentThe hidden scaling challenges that have persisted since 2002 and continue to impact gene therapy manufacturingKey Insights:Dr. von Stosch reveals how the separation of tasks between people who run processes, analyze samples, and model data creates a cascade of documentation errors and missed assumptions. From transfection efficiency challenges to capsid filling ratios, he explains why "if we didn't document it, if we didn't measure it, then we'll have a hard time with the modeling."Critical Takeaway: Process development should focus on answering specific questions, not modeling for modeling's sake. As Moritz emphasizes: "If you have a model which is good enough to answer the question at hand, that model is good enough."Perfect for: Cell and gene therapy process development engineers, manufacturers, operations and technical leaders wrestling with scale-up challenges.Guest: Dr. Moritz von Stosch brings 20+ years of digital bioprocessing expertise from academia and industry, including leadership roles at GSK and as Chief Innovation Officer at Dathera, specializing in hybrid modeling for bioprocess optimization.Method Made explores operational challenges in bioprocessing with a focus on cell and gene therapy manufacturing.

In the high-stakes world of cell and gene therapy, we assume our challenges are unique. But what if the biggest threat to your tech transfer is a universal problem your team is blind to?In this episode of the Method Made podcast, Nicholas talks with David Horesh, a CEO who witnesses the same critical communication failure across dozens of industries—from aerospace and defense to cutting-edge biotech. The problem? Scientists and engineers are not speaking the same language, and it's killing innovation.David's cross-domain experience provides a unique set of "meta-lessons" for the cell and gene therapy space. We funnel his global insights to reveal what CGT teams can learn from mistakes made in entirely different fields.This episode is a masterclass for CGT professionals on:The Universal Blind Spot: Recognizing the hidden language gaps that even the most specialized teams take for granted.Beyond Pharma: How communication breakdowns in mining and quantum physics offer a blueprint for what to fix in your lab.De-Risking Your Tech Transfer: Why understanding this universal communication flaw is a critical de-risking strategy for scaling therapies from R&D to manufacturing.The Real Root Cause: Moving beyond SOPs to see how these language gaps create the operational friction that stalls your timeline before a process is ever documented.If you work in cell and gene therapy, this conversation offers an invaluable outside perspective. It exposes the fundamental communication challenges you didn't know you had and provides a new framework for ensuring your science translates flawlessly into scalable manufacturing.

Ever wonder why cell and gene therapy manufacturing is so expensive? CDMO veteran Steven Keizer (15+ years experience) reveals a shocking operational reality: these procedures literally require two people to do what should be a one-person job.In this episode, Steven breaks down:Why sterile manufacturing forces operators to work with a dedicated scribeHow this violates FDA documentation requirements (but is necessary for patient safety)The fundamental disconnect between R&D teams who want blank pages and operators who need templatesWhen biotech companies should start thinking about tech transfer (hint: much earlier than you think)Quality by design principles that can save millions in failed engineering runsSteven has worked across large pharma and CDMOs, giving him unique insight into both sides of the tech transfer equation. Whether you're scaling your first process or your tenth, this conversation will change how you think about documentation.Key topics: Tech transfer, SOP documentation, cell and gene therapy, GMP manufacturing, quality by design, CDMO operationsmethodmade.ca

I asked Marina Goldfield this exact question on my latest podcast episode. Marina has 20 years of hands-on experience in biological manufacturing.Her answer was unequivocal:"Absolutely everything needs to be written down. There is no level of detail that's going to be too much. In my experience, it's always not enough."Marina explained that teams consistently discover missing details after problems occur: "You always figure out at the end like, oh, we should have written this down."The root cause? Not having detailed conversations during the tech transfer process.When it comes to cell culture, Marina emphasized: "It unfortunately all matters and it's all cumulative. All of these little changes collect together and have a synergistic effect."For biotech companies approaching their first tech transfer: Don't underestimate the level of detail required. What seems like "obvious" knowledge to your team can be the missing piece that causes expensive batch failures downstream.The takeaway: If you're questioning whether to document something - document it. According to Marina, there's no such thing as too much detail in tech transfer.

Pharma consultant Michele Bruschi breaks down why 80% of CDMOs and biotechs are still managing critical operations with spreadsheets and PDFs - and how this data crisis is creating massive competitive advantages for the companies that solve it.In this episode, we explore:Why "endless searching" for SOPs is costing weeks on every projectHow disconnected systems create operational chaos across the industryWhy efficiency and speed have replaced capacity as key differentiatorsThe hidden costs of fragmented data management (13:49)What operational differentiation actually looks like in practice (20:08)Michele's prediction on which companies will survive the current market consolidationMichele brings insider perspective on the pharmaceutical industry's data management challenges and reveals why now is the critical moment for digital transformation in bioprocessing.Whether you're a biotech approaching tech transfer or a CDMO looking to differentiate, this conversation explains the operational realities shaping partnership decisions today.Guest: Michele Bruschi, Pharmaceutical Industry ConsultantHost: Nicholas Crudele, Method Made

Cell and gene therapy faces a brutal reality: while traditional drugs make millions of doses per batch, personalized medicine makes one dose per patient. Yet each dose requires the same documentation burden - resulting in 16 three-ring binders and over 1,000 pages of paperwork per batch.In this episode, Jason Foster from Ori Biotech breaks down two critical bottlenecks killing industry scale-up:The Equipment Mismatch:Academic labs develop therapies using T-flasks and manual toolsCDMOs use completely different manufacturing equipmentCompanies must rebuild their entire process during tech transferNormal timeline: 9-12 months per transferThe Documentation Nightmare:Order of magnitude more batches than traditional biologicsSame regulatory documentation requirements per batchTwo people manually reviewing every pageMost facilities still operating on paperJason shares how Ori reduced one tech transfer from 9-12 months to 2 weeks by standardizing equipment across research and manufacturing: "Tech transfer becomes pushing a button - the protocol transfers to another system that still knows what to do."We also discuss the "curse of knowledge" problem - when PhD experts leave (average cleanroom retention: less than 1 year), critical tribal knowledge walks out the door.Key insights on why the industry needs tools built specifically for personalized medicine, not retrofitted from 20-year-old biologics infrastructure.Guest: Jason Foster, Ori BiotechHost: Nicholas Crudele, Method Made

Nithya shares what she's learned from years in CDMO business development and technical operations. From the post-pandemic CDMO boom to today's "minimum viable process" reality, she breaks down why small biotechs struggle with tech transfer documentation.Key insights:Why PowerPoint presentations aren't tech transfer documentation (and CDMOs are saying no)The mindset shift from academic protocols to manufacturing SOPsHow engineering runs become make-or-break decisions for cash-strapped biotechsWhy treating R&D as a scale-down model of manufacturing changes everythingThe hidden costs of not thinking like a product manager from day oneNithya explains the communication breakdowns between brilliant scientists and manufacturing experts - and what it takes to bridge that gap successfully.Perfect for biotech founders, process development teams, and anyone navigating the transition from discovery to manufacturing.

In this eye-opening episode, we sit down with Heather, a seasoned business development expert at Chrysalis Bio, who reveals the hidden communication breakdowns that derail tech transfers long before any scientific issues arise.What You'll Learn:Why most companies approach tech transfer reactively instead of proactively—and how this costs millionsThe shocking disconnect between business development and operations that leads to "wrong client" scenariosHow 30% attrition in analytical teams still doesn't solve communication problemsThe three ways CDMOs grow in the market (and why two approaches are fundamentally flawed)Why proximity matters less than you think, but supply chain management could be your biggest differentiatorThe untapped opportunity in case management that most CDMOs are missingKey Insight: "You don't have those systems in place, so you're forcing a process to happen based on need versus based on understanding. Information can get lost. Disconnects can happen, wrong information gets transferred, timelines then get pushed out."Heather shares real-world examples from her experience in cell and gene therapy CDMOs, revealing how the industry's rapid growth has created expertise gaps and why building proactive communication systems is critical for success.Whether you're a startup planning your first tech transfer or a CDMO looking to differentiate your services, this episode provides actionable insights for preventing the costly miscommunications that plague the industry.Perfect for: Biotech executives, CDMO professionals, process development teams, and anyone involved in technology transfer in life sciences.

In this episode, I'm joined by Brian Newsom, CEO of Carrigent. We discuss the challenges in effective tech transfer in the Cell and Gene Therapy industry. This includes effective documentation in CGT, why nuanced detail capture in SOPs is mission critical during tech transfer, and the different risk profiles of effective documentation between personalized medicine and generic drug production.

In this episode, we discuss some of the challenges and requirements for effective tech transfer from the perspective of biofuel bioprocessing expert Shekar Govindaswamy Ph.D.