Hi Anonymous,
As you indicate the Endosafe nextgen-PTS is designed to be used at point of use (in-process samples). At this point, I have no evidence that FDA has accepted this system as a replacement to USP 85. As with any method, if you can demonstrate suitability as an alternative to the USP 85, then I would propose you submit the objective evidence with your pre-IND meeting package and have FDA agree or not with the method. Alternatively, your Phase 1 studies should be small enough batches that using the USP 85 would not be a hardship to release or stability and to ensure "safety" of the material at such an early phase. I don't know if you company is risk tolerant or averse but if you put together the right justification with data FDA would consider it and respond to a question. I would run the USP method for my own "peace of mind" on early research or engineering batches in parallel with the Endosafe nextgen-PTS prior to any "replacement" of a currently recognized USP method.
Great topic, am lookin forward to other perspectives or real world experiences,
Dar
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Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
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Original Message:
Sent: 30-Dec-2021 00:02
From: Anonymous Member
Subject: CMC - endotoxin - Endosafe nextgen-PTS?
This message was posted by a user wishing to remain anonymous
Hi all,
Can one use Endosafe nextgen-PTS (Endosafe® nexgen-PTS™) for testing endotoxin instead of the lengthy kinetic chromogenic LAL testing from USP 85? I think it is ok to use this PTS reader for in-process samples, but I am not sure if we can use it for release and stability testing. For your information, our company is mainly manufacturing phase I drug products.
Thank you!