Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We are a small company working on mAbs. With DP stability studies, can we store vials at the inverted position rather than all three positions (upright, horizontal, and inverted)? Our justification is that the inverted position represents the worst-case scenario. The stability testing, especially the potency tests, consumes many resources, and we would like to cut the cost.

Thank you.

This message was posted by a user wishing to remain anonymous

Minimum upright and inverted would be my recommendation! This would be helpful in the long run once your candidate moves forward in development!
Original Message:
Sent: 20-Jun-2022 07:38
From: Anonymous Member
Subject: Stability Vial Position during Phase I

This message was posted by a user wishing to remain anonymous

Hello,

We are a small company working on mAbs. With DP stability studies, can we store vials at the inverted position rather than all three positions (upright, horizontal, and inverted)? Our justification is that the inverted position represents the worst-case scenario. The stability testing, especially the potency tests, consumes many resources, and we would like to cut the cost.

Thank you.

We've always done both upright & inverted, as far as I know. That doesn't mean you can't - I just don't have experience to say you can. I would recommend you have a documented technical justification for why the inverted position is worst-case (don't just assume it's obvious). It's just that the impact if it's not accepted could be huge. As a compromise, you could only test upright for the most critical tests and/or conditions (again, with documented technical justification).

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Rachel Thornton
Associate Director
Smyrna GA
United States
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Original Message:
Sent: 20-Jun-2022 07:38
From: Anonymous Member
Subject: Stability Vial Position during Phase I

This message was posted by a user wishing to remain anonymous

Hello,

We are a small company working on mAbs. With DP stability studies, can we store vials at the inverted position rather than all three positions (upright, horizontal, and inverted)? Our justification is that the inverted position represents the worst-case scenario. The stability testing, especially the potency tests, consumes many resources, and we would like to cut the cost.

Thank you.