It is not required to monitor on release. There is an expectation that you will monitor and characterize particles in this range, but the details are fuzzy. Using the SVP method for particles in that range is not very informative b/c the results are highly variable and challenging to interpret. We tend to focus on attention on characterizing high molecular weight species through other methods (SE-HPLC, svAUC). We do collect the data on 2-10um particles from the SVP method, but we don't do a lot with it. We have never been asked anything about 2-10um particles, so it seems what we're doing is sufficient.
I could imagine that if there were a major immunogenicity issue authorities might want you to dig more into it, but I haven't seen that happen.
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Rachel Thornton
Associate Director
Smyrna GA
United States
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Original Message:
Sent: 29-Jun-2022 20:00
From: Anonymous Member
Subject: Particulate characterization for mAb products
This message was posted by a user wishing to remain anonymous
Good people of the RAPS community,
For monoclonal antibody products, are particles in the 2-10 um range required to be monitored on release testing or characterized in development studies? If yes, is there a typical phase of development when this becomes necessary? And is there an acceptable threshold for particulates in the 2-10um range for IV use? Finally, is this type of testing driven by the immunogenicity profile of the mAb in question?
Thank you,
Anon