Endotoxins and Pyrogens - Which test to be used? This is a question that many biopharmaceutical manufacturers are currently asking themselves.
In recent years, there has been much discussion about the extent to which test systems based on LAL have detection gaps in biopharmaceutical products and whether masking effects pose a risk to the product and to patients. Is there a reduced recovery rate and if so, what strategies can I use to counteract this effect? Further, other controversial views are also preoccupying the expert community - like the question, to what extent a test based on the availability of a single species - namely the horseshoe crab - is still up-to-date in times of climate and environmental catastrophes and under animal protection aspects. Shouldn't test systems based on recombinant factors be established and perhaps even be given preference?
Referring to these discussions are the recently issued new draft chapter on Recombinant Factor C (rFC) in the European Pharmacopoeia. In addition, the Japanese Pharmacopoeia is also currently considering this.
The Live Online Endotoxin and Pyrogen Conference at PharmaLab 2020 from November 10-11 will provide information on the current status of these developments, which methods are used when - and the pros and cons.