New Wave of Sustainable Endotoxin Testing Reaches 503Bs
Over the past decade, large pharmaceutical manufacturers have proposed a wave of new measures to adopt sustainable practices designed to lower carbon emissions, reduce waste, seek alternatives to animal-derived materials and so on.
More recently this trend has shored up at 503B compounding pharmacies where they continue to implement current good manufacturing practices (cGMP) similar to those followed by big pharma. One of these sustainable measures involves bacterial endotoxin testing (BET). USP <797> (12.3 Bacterial Endotoxins Testing) requires that compounded sterile preparations do not exceed the endotoxins limit calculated as described in USP <85>.1
Now the USP is turning the page on chapter <85> and taking steps toward sustainable endotoxin testing practices using non-animal derived recombinant reagents. The USP announced in August 2023 the development of a new chapter for the use of additional reagents for bacterial endotoxins testing. The proposed chapter, <86> Bacterial Endotoxins Test Using Recombinant Reagents, would provide additional techniques using nonanimal derived reagents to the Bacterial Endotoxins Test <85>.2 This proposal will include methods for recombinant Factor C (rFC) and recombinant cascade reagents (rCR).2
The measure is intended to help drive the adoption of recombinant reagents as alternatives to naturally sourced reagents from horseshoe crabs, as stated in a general announcement by the USP. This approach advances USP’s commitment to transition methods from using animal-derived materials to synthetic and recombinant materials.2
As 503B outsourcing facilities prepare to usher in the new era of BET using recombinant reagents, the USP document Chapter <86>: Frequently Asked Questions3 provides answers to some key questions. Read USP Chapter <86>: Frequently Asked Questions here.
Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents is now published as a General Announcement in advance of the official open comment period, which will run from Nov. 1, 2023 through Jan. 31, 2024.
REFERENCES
1 <797> Pharmaceutical Compounding—Sterile Preparations. USP.org. Nov. 19, 2022. *797 PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS (uspnf.com)
2 <86> Bacterial Endotoxins Test Using Recombinant Reagents. USPNF.com. Aug. 22, 2023. Bacterial Endotoxins Test Using Recombinant Reagents | USP-NF (uspnf.com)
3 Chapter <86>: Frequently Asked Questions. USP.org. gss_sa_004_f_chapter86_2023-08_final3.pdf (usp.org)
