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PODCAST

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

In the competitive cell and gene therapy landscape, speed and efficiency are paramount. The biggest roadblock? The operational friction in tech transfer. This podcast is for executives focused on building a durable competitive advantage. We explore how to transform tech transfer from your biggest risk into your greatest asset. By solving the deep operational challenges and aligning perfectly with your CDMO partner, you can shorten timelines, protect capital, and get your therapy to patients faster

science life sciences

All Episodes

00:40:23

The Light in the Lab: Why a Single Missed Detail Can...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/11/12

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,

en-ca

00:37:43

The Time Bomb in Your Tech Transfer: Why Tacit...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/10/04

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

en-ca

00:43:23

Beyond the Brochure: Mastering the CDMO Partnership...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/09/23

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

en-ca

00:44:41

From Data to Scale: How Workplace Silos Break...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/08/14

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

en-ca

00:22:21

Why Your Gene Therapy Tech Transfer Fails (A Lesson...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/08/05

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

en-ca

00:20:20

Why Cell & Gene Therapy Manufacturing Needs Two...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/07/30

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

en-ca

00:16:29

How Much Detail Is Too Much in Tech Transfer...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/07/29

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

en-ca

00:33:07

The Data Crisis Killing Pharma Efficiency with...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/07/09

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

en-ca

00:25:52

Why cell & gene therapy tech transfer takes 9-12...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/05/23

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

en-ca

00:45:21

CDMO Veteran Nithya Jesuraj Reveals the Documentation...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/05/23

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

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00:25:40

"You Don't Know What You Don't Know": Why Tech...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/05/22

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

en-ca

00:22:06

Tech Transfer in Cell & Gene Therapy

Method Made: The Tech Transfer Edge in Cell &... ·

2025/05/02

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.

en-ca

00:14:53

What Cell & Gene Therapy Can Learn About Tech...

Method Made: The Tech Transfer Edge in Cell &... ·

2025/05/02

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.

en-ca

13 results

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