TL;DW:
Due to various molecular configurations (aka polymorphs), currently known medicines when contaminated with a catalyst seed molecule/particle can become irreversibly unreproducible via chained-contaminations.
- the contamination can cause the existing configurations to become more stable in a negative fashion where the medicine/compounds no longer work they way we expect them to.
This system of contamination and reproduction acts in similar fashion to viral infections.
Current Solutions:
- better clean room procedures for all steps of medicine manufacturing.
- pour more money into medicine polymorph research.
Oh man, give me a scientific issue any day of the week. I would much rather deal with some investigation rather than work on an IND, BLA, or MAA section to submit to an agency. I have tremendous respect for reg folks that can make sense of the agency guidance. Thank you for your service!
Same. But if I was back in the lab, would I want to do something outside of it? I don't know. I do miss lab stuff though.
Maybe evaluation would be more accurate or a term, I'm the one in part reviewing the submissions at the agency.
Thank you for what you do as well, I think the industry portion sounds more interesting than my end haha.