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.
Coming from a regulatory area, it’s interesting to hear about this from a manufacturer point of view.
Great and very accurate post.
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.
Regulatory? Nice to hear some of you survived till today. Good luck buddy, I’m rooting for you!
Thanks! We’re actually actively hiring due to backlogs of drug submissions. I definitely prefer the chemistry aspect to equipment validation and such, but what can you do?