Polycarbonate drug substance container closure and OOS for concentration only

[ksparkman]

#24936

Hello stability friends,

has anyone experienced a concentration (SoloVPE) out of specification at -60c on stability? No other test attributes at this storage condition are OOS, but the material is frozen in polycarbonate containers for reference.

[John O’Neill]

#25032

Hello,
I see by the lack of responses that our subscribers seem to have little experience with regard to your question. I am among that group, but in order to potentially stir the pot, I would ask if there might be any chance that the concentration might be due to aggregation? I have experienced aggregation around -60C in metal containers that had minute imperfections in the surface of the vessels. I would guess that polycarbonate does not display these types of imperfections, but perhaps you could confirm this.

[Author]

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