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.
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?