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!
Regulatory? Nice to hear some of you survived till today. Good luck buddy, I’m rooting for you!