Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi RAPS,

I wonder if both small molecules and biologics (monoclonal antibody) are both subject to the rule for extending shelf life beyond the available long-term period stated in the ICH Q1E? 

In ICH Q5C, it described that the requested storage period should be based on long term, real time and real temperature stabilitystudies. 
In ICH Q1E, the rule for extending shelf life beyond the available long-term period is clearly stated. 

Do biologics (monoclonal antibodies) have a shelf life extension rule same as that described in ICH Q1E?

In the  EMA/CHMP/BWP/534898/2008 rev1, it did state that "The requested storage period should be based on long term, real time and real temperature stabilitystudies, as described in ICH Q5C. However, extension of the shelf-life beyond the period covered byreal-time stability data may be acceptable, if supported by relevant data, including accelerated stabilitystudies and/or relevant stability data generated with representative material."

Is shelf-life extension also acceptable to the US FDA ?

Thanks,

This message was posted by a user wishing to remain anonymous

these are simple CMC RA questions! Please consult with your RA-CMC person. If you don't have one, please hire someone quickly!
Original Message:
Sent: 07-Nov-2021 21:01
From: Anonymous Member
Subject: Shelf life determination (monoclonal antibody )

This message was posted by a user wishing to remain anonymous

Hi RAPS,

I wonder if both small molecules and biologics (monoclonal antibody) are both subject to the rule for extending shelf life beyond the available long-term period stated in the ICH Q1E?

In ICH Q5C, it described that the requested storage period should be based on long term, real time and real temperature stabilitystudies.
In ICH Q1E, the rule for extending shelf life beyond the available long-term period is clearly stated.

Do biologics (monoclonal antibodies) have a shelf life extension rule same as that described in ICH Q1E?

In the  EMA/CHMP/BWP/534898/2008 rev1, it did state that "The requested storage period should be based on long term, real time and real temperature stabilitystudies, as described in ICH Q5C. However, extension of the shelf-life beyond the period covered byreal-time stability data may be acceptable, if supported by relevant data, including accelerated stabilitystudies and/or relevant stability data generated with representative material."

Is shelf-life extension also acceptable to the US FDA ?

Thanks,