EP8 - Duncan Ross on Producing Stem Cell Exosomes at Scale

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In this episode, Dr. Ed Park sits down with Dr. Duncan Ross, PhD immunologist and founder of Kimera Labs, to discuss the real science behind exosome manufacturing, quality control, and why most exosome products on the market are not what they claim to be.

Duncan shares the origin story of exosomes—how he discovered their regenerative potential by accident when trying to help his partner's wife with COPD. They dive deep into exosome characterization, the myth of "particle counting," why cargo matters more than numbers, and how to distinguish between legitimate products and dangerous knockoffs. You'll learn about FDA inspections, contamination risks, the difference between exosomes and conditioned media, and why amniotic fluid exosomes lack RNA payload.

They also discuss the future of tissue-specific exosomes, FDA approval pathways, and investment opportunities for venture capitalists interested in bringing exosome therapies to market.

Topics covered:
– The origin of exosome discovery and Kimera Labs
– How exosomes reprogram aging cells
– Exosome characterization: particle counting vs. cargo analysis
– Why "more particles for less money" is a red flag
– FDA inspections and warning letters
– Contamination risks and safety testing (40 pathogens)
– Sterility, potency, and reproducibility
– Conditioned media vs. isolated exosomes
– Placental matrix and Wharton's jelly: safety concerns
– Amniotic fluid exosomes: RNA payload and limitations
– Allogeneic stem cells: immune rejection and engraftment
– Size exclusion filtration and quality assurance
– Exoview technology and CD63/CD81 markers
– RNA and protein concentration as potency measures
– Stress on cells and exosome quality
– Tissue-specific exosomes (chondrogenic, neural, ovarian)
– FDA approval pathways and clinical trials
– Manufacturing standards and facility requirements
– Investment opportunities and venture capital partnerships

Resources:
– Books: "Telomere Timebombs," "The Telomere Miracle," "Exosomes: Songs of Healing"

Books by Dr. Park:
"Exosomes: Songs of Healing" | https://tinyurl.com/exohbook
"The Telomere Miracle" | https://tinyurl.com/ttmbook
"Telomere Timebombs" | https://tinyurl.com/ttbbook

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