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