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Machine Learning in AAV Manufacturing: What's Real, What's Not, and How to Tell

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  What the published evidence actually supports, and what's being sold ahead of it. By Fatma Elzahraa Eid , PhD | TheBioMLClinic Brief disclosure: I am an independent AAV-ML scientist with two decades of experience in machine learning and biological problems, and I provide vendor evaluation and technical due diligence services through TheBioMLClinic, which means I have a direct professional interest in the topic of this post. The vendor archetypes described are illustrative composites drawn from public market activity, not characterizations of any specific company. This post does not constitute procurement, investment, business, or regulatory advice. Full disclosures at the bottom. Sit through enough pitch meetings about AI for AAV manufacturing and you start to notice a pattern. The slides are clean. The founders' pedigrees are real. The funding is increasingly serious. And the numbers, when there are numbers, sit at very different tiers of evidence than the confidence of the...
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Capsida's Trailblazing Moment: What the Field Owes the Next BBB Program

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  By Fatma Elzahraa Eid , PhD | TheBioMLClinic Brief disclosure: I am a named inventor on patents and author on publications related to AAV capsid engineering and CNS gene delivery, developed during my time at the Broad Institute. I now operate independently. This post does not represent any prior employer, current advisory client, or collaborator. The mechanistic analysis presented here is my own scientific interpretation of publicly available data. Full disclosures at the bottom. A child died. Brain swelling (cerebral edema) within days of receiving a gene therapy that had cleared every preclinical safety bar the field knows how to set. The IND had FDA clearance. The Good Laboratory Practice (GLP) toxicology study showed no adverse histopathology. The capsid achieved greater than 70% neuronal transduction across critical brain areas in nonhuman primates. By every metric the field currently uses, this program was ready. And yet. This post is not about assigning blame. Cap...
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