Method Made: The Tech Transfer Edge in Cell & Gene Therapy – Détails, épisodes et analyse

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

Nico

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Fréquence : 1 épisode/16j. Total Éps: 13

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. Move beyond day-to-day problems and learn to build a tech transfer strategy that wins.

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https://www.methodmade.ca/
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The Time Bomb in Your Tech Transfer: Why Tacit Knowledge is Your Biggest Business Risk

samedi 4 octobre 2025 • Durée 37:43

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

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

mardi 23 septembre 2025 • Durée 43:23

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 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.

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Tech Transfer in Cell & Gene Therapy

vendredi 2 mai 2025 • Durée 22:06

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.

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What Cell & Gene Therapy Can Learn About Tech Transfer From Biofuels

vendredi 2 mai 2025 • Durée 14:53

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.

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From Data to Scale: How Workplace Silos Break Bioprocessing Models

jeudi 14 août 2025 • Durée 44:41

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 of 10-20% still plague new modalities in cell and gene therapy
How separation between operators, sample analyzers, and modelers introduces dangerous assumptions
Why standardization gaps across sites and raw material lots sabotage process development
The hidden scaling challenges that have persisted since 2002 and continue to impact gene therapy manufacturing

Key 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.

Why Your Gene Therapy Tech Transfer Fails (A Lesson from Outside Pharma)

mardi 5 août 2025 • Durée 22:21

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.

Why Cell & Gene Therapy Manufacturing Needs Two People to Do One Job with Steven Keizer

mercredi 30 juillet 2025 • Durée 20:20

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 requirements (but is necessary for patient safety)
The fundamental disconnect between R&D teams who want blank pages and operators who need templates
When 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 runs

Steven 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 operations

methodmade.ca

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How Much Detail Is Too Much in Tech Transfer Documentation?

mardi 29 juillet 2025 • Durée 16:29

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 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.

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The Data Crisis Killing Pharma Efficiency with Michele Bruschi

mercredi 9 juillet 2025 • Durée 33:07

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 across the industry
Why efficiency and speed have replaced capacity as key differentiators
The 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 consolidation

Michele 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

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Why cell & gene therapy tech transfer takes 9-12 months (and costs millions) with Jason Foster, CEO of Ori Biotech

vendredi 23 mai 2025 • Durée 25:52

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 tools
CDMOs use completely different manufacturing equipment
Companies must rebuild their entire process during tech transfer
Normal timeline: 9-12 months per transfer

The Documentation Nightmare:

Order of magnitude more batches than traditional biologics
Same regulatory documentation requirements per batch
Two people manually reviewing every page
Most facilities still operating on paper

Jason 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 Biotech
Host: Nicholas Crudele, Method Made

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Method Made: The Tech Transfer Edge in Cell &amp; Gene Therapy – Détails, épisodes et analyse

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Method Made: The Tech Transfer Edge in Cell & Gene Therapy – Détails, épisodes et analyse