Out of the Lab: Operationalizing Cell and Gene Therapy

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.