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To answer the main question -Why is this LAL test so important?-
Because when your half and end products are proteins (like vaccins) you cannot sterilise them. Any standard method used for sterilising (autoclave, radiation, EO, formaldehyde…) destroys proteins because that is actually the whole point of these methods.
To make matters worse in biotech many half products would actually serve well as a broth to grow bacteria in (proteins, sugars, nicely buffered, isotone…) so even the smallest amount of bacteria can grow into a serious problem anywhere in your process stream very fast.
Filtering helps but filters can fail. Bioburden tests can only tell you if a (growable) bacteria is in your sample now, not if there have been one dumping its nasty toxins(*) in it anywhere upstream.
So we need a test, a test to tell us with extremely high confidence that there are no endotoxins and we need to test our product streams constantly. And although there are alternatives (MAT, rec. fC) they are still not as well trusted and practical application of these has to wait until authorities even allow it.
For now we are stuck with LAL. You want safe vaccins, you need horseshoe crab blood.
(*I know biotech, I can use that word :D)
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We have/had them in Boston Harbor on the Harbor Islands. Ugly critters but not nearly as large as the ones they are miking for blood. This was back in the early 1970s. Boston has since almost literally burnt the bridges that would give you access to them. Although you can actually walk to one when the tides are right.
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But wasn’t the whole point of the video that there is now a (patented) method of using a substitute that obviates the need for actual horseshoe crab blood?
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Already in use in the EU.
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