Andrew Hillman's 2026 manuscript on why Wharton's jelly stem cell exosomes require BLA licensure under Section 351(a), and what that classification means for manufacturing. We cover the four-criteria test, cGMP and ISO and ICH quality systems, Type I glass, the minus 80 degree cold chain, and the labeling problems the paper sees in grey market products. Exosome products are not approved by the FDA for any indication. Hosted by Andrew Jonathan Hillman, Dallas, Texas. Permanent record (DOI): https://doi.org/10.5281/zenodo.21169929 Main site: https://andrew-hillman.com/ Publications: https://andrew-hillman.com/publications/ This episode is educational and is not legal or medical advice. Andrew Hillman is not an attorney. Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used. Links and resources: Companion paper: https://andrew-hillman.com/publications/whartons-jelly-msc-exosomes-351a-classification/ Podcast home: https://andrew-hillman.com/podcast/ About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/ LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas The Hillman Letter on Substack: https://thehillmanletter.substack.com Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190 Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4 Academia.edu, SMU: https://smu.academia.edu/AndrewHillman ORCID: https://orcid.org/0009-0001-5396-321X Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman Book a call: https://calendly.com/ajhusa Educational only. Not legal advice. Not an attorney.