To get to a world where every disease is cured and there's a medicine for everything, we need far more experiments than people can run.
That means many dark labs: lights off, only robots and agents working, around the clock.
Europe's draft rulebook for AI in drug manufacturing says LLMs "should not be used in critical GMP applications."
The industry pushed back, and the EU is reworking the text now.
My bet: the bar won't become "trust the model." It'll become "show me where every number came from."
The FDA's first warning letter about AI in drug manufacturing has my favorite line of the year.
The firm skipped a required step and told the FDA it didn't know, because the AI agent "never told you it was required."
AI can write your SOPs. It can't take the inspection for you.