Regulatory Open Forum

Hi everyone,

I'm not sure if this question is appropriate for this forum, if not, please let me know which forum I can go to post such a question. This is about the endotoxin testing.

Since endotoxin assay (LAL kinetic) is a compendial assay, I understand that a sponsor typically has to perform assay verification using 3 lots of material. Here are my questions:
1. Do all 3 lots have to come from at-scale productions?
2. Do they need to be GMP lots? Can a non-GMP lot be used?
3. For a phase 1 program, what's the typical strategy for endotoxin assay verification?

4. Does the endotoxin test have to complete verification before the first GMP material release? If so, what material to use and how to achieve that

Thank you.

Hi Anon,

For phase 1 program, you don't have to have 3 lots at scale nor GMP lots. It will be recommended to have it verified by a tox lot before your first GMP at scale lot is released.