TY - JOUR T1 - Application of recombinant Factor C reagent for the detection of bacterial endotoxins in pharmaceutical products JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2017.007849 SP - pdajpst.2017.007849 AU - Jay S Bolden AU - Kelly R Smith Y1 - 2017/01/01 UR - http://journal.pda.org/content/early/2017/07/17/pdajpst.2017.007849.abstract N2 - Recombinant Factor C (rFC) is non-animal derived reagent used to detect bacterial endotoxins in pharmaceutical products. Despite the fact that the reagent was first commercially available nearly 15 years ago, the broad use of rFC in pharmaceutical industry has long been lagging, presumably due to historical single source supplier concerns and the lack of inclusion in worldwide pharmacopeias. Commercial rFC reagents are now available from multiple manufacturers, thus single sourcing is no longer an issue. We report here the successful validation of several pharmaceutical products by an end-point florescence-based endotoxin method using the rFC reagent. The method is equivalent or superior to the compendia bacterial endotoxins test (BET) method. Based on the comparability data and extenuating circumstances, the incorporation of the end point fluorescence technique and rFC reagent in global compendia BET chapters is desired and warranted. ER -