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9.
Conclusion
The current
focus with endotoxin testing is with the transition
away from animal-derived lysates and towards recombinant
factor C reagents. The steps this takes is still transitional in terms of
compendial development, validation versus verification requirements,
and regulatory approval; nonetheless, the eventual replacement
of horseshoe crab lysate with a recombinant product is inevitable.
Longer term, recombinant lysate might be replaced by biosensor
technology, including optical, electrochemical, photoelectrochemical,
and electrochemiluminescence solutions.22
For the immediate future,
recombinant factor C (and recombinant forms of the endotoxin
reactive pathway) is here to stay, and the focus needs to be as much
with reliable methods of manufacture as it is with reagent qualification.
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