Out of the Lab: Operationalizing Cell and Gene Therapy

Why does a process that works perfectly in a university lab suddenly fail when it hits a manufacturing facility? In this episode, we sit down with François-Xavier (FX) Lacasse , a 28-year industry veteran, to unpack the notorious friction of tech transfer. We dive into the fundamental language barrier between academia ("research for research") and industry ("research for development...

In this episode, host Nico sits down with repeat guest Lee Buckler to tackle the "80/20" problem in cell and gene therapy: the fact that while 80% of patients are treated in community settings, CAR-T therapies are currently stuck in high-level academic centers. We explore the history of patient access from the stem cell transplant model to the lessons learned from Dendreon’s Provenge and...

In the current investment landscape, the "cool science" era of Cell and Gene Therapy is over. Investors have moved from unbridled optimism to rigorous risk management, yet many IP-backed companies still treat manufacturing as an afterthought, a strategic error that kills margins and delays clinics. In this episode, Nico sits down with Silvio Tiziani, CEO of CCRM Australia, to dissect the...

"The number one hashtag on everybody's lips is patient accessibility ." In this pre-episode teaser, we dive into the sobering reality of the "80/20 Gap" in cell and gene therapy. While the industry has celebrated the arrival of highly curative CAR T-cell therapies, a massive logistical wall has been hit. Lee Buckler joins us to unpack why sales of these "wonderful widg...

"The tradition is we start with open manual processes: flasks and clean rooms, thinking we can automate and scale and worry about cost of goods later." In this episode, Lee Buckler (Cell Therapy Group) and Nicholas Crudele (Method Made) explore why the "science project" phase of Cell & Gene Therapy often leads to a tech-transfer dead end. But the answer isn’t necessarily lo...

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...

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...

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 sto...

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 s...

Beyond the Brochure: Mastering the CDMO Partnership for Successful Tech Transfer with Klaus Dörre How 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 gen...

From Data to Scale: How Workplace Silos Break Bioprocessing Models In 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...

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 biot...

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 scribe How this violates FDA documentation requirem...

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...

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 project How disconnected systems create operational chaos...

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:...

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...

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 millions The shocking disconnect between business developm...

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.