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>Biomedical/pharmaceutical companies are reluctant to devote time and resources to qualify an alternative method as they are concerned that regulators will not
by drzaiusapelord 10y ago
>Biomedical/pharmaceutical companies are reluctant to devote time and resources to qualify an alternative method as they are concerned that regulators will not accept the alternative method. However, the pharmacopeia publications include chapters that directly address what is needed to qualify an alternative method so that it will be acceptable by regulators.
Classic chicken and egg problem here. These companies don't want to invest in the lengthy regulatory approval process because they aren't sure they'll pass so progress on these alternative methods gets stalled, thus ensuring they look sub-optimal on paper, so the perceived risk level is probably higher than it should be.
Considering there are two alternatives here, one involving synthetically cloning DNA and the other simply using human blood, I can probably see why industry is slow to move off the crab blood process. The former is most likely much more expensive and patent encumbered, while the later involves harvesting humans instead of crabs. Human blood is needed for transfusions and has a high demand, so it makes sense to just use animal blood for endotoxin testing.
[1]http://www.horseshoecrab.org/med/alternatives.html http://www.horseshoecrab.org/med/alternatives.html
- beaconstudios 10y agocould the blood not be taken from the dead? Blood is already drained in the embalming process. I'm guessing it'd need consent similar to organ donation though.
- drzaiusapelord 10y agoMost people die quietly in hospice or at home, not in the ER, so there's a logistical problem here. Red blood cells start dying in minutes after host death, so you don't have a lot of time on your hands in common scenarios. Biologically, you want healthy blood full of red blood cells not blood low on red blood cells and full of white blood cells which can cause complications. The dead also can't answer questions about their illness history. There's a lot of legwork with blood that organs don't typically require.
- LordKano 10y agoThe Russians did some research into cadaveric blood transfusions. The blood is still usable for several hours after clinical death. I'm not sure about the suitability of using blood from old, sick and/or heavily medicated people.
- deleted 10y ago[deleted]
- beaconstudios 10y agois it not possible to find out the relevant answers re. illness history (I'm guessing antibody presence?) from analysing the blood itself? I would've thought that all relevant answers about the blood's qualities would be detectable from the blood itself.