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  • 1.  How much DS stability data is required for an IND?

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jul-2019 09:12
    This message was posted by a user wishing to remain anonymous

    Does drug substance (DS) stability need to be presented in an IND for a biologic in oncology? The FDA has agreed to our plan to file on 1 month drug product (DP) stability data with more extensive DP stability from an engineering lot. My question is how much DS stability data needs to be shared.
    The issue is not that we don't want to share the data, just a question of when it'll be available and whether it should hold up the IND.
    Any guidance would be appreciated!


  • 2.  RE: How much DS stability data is required for an IND?

    Posted 25-Jul-2019 09:47
    Hello!

    I am assuming that your biological product is in Phase I with my response below. However, if you are further along in development, then phase appropriate stability data should be presented.

    The guidance doc titled, "Content and Format of Investigational New Drug Applications (INDs) for Phase1 Studies of Drugs, Including Well Characterized, Therapeutic, Biotechnology-derived Products - November 1995" states the following related to DS stability data:

    ...although stability data are required in all phases of the IND to demonstrate that the new drug substance and drug product are within acceptable chemical and
    physical limits for the planned duration of the proposed clinical investigation, if very short-term tests are proposed, the supporting stability data can be correspondingly very limited.

    Information to support the stability of the drug substance during the toxicologic studies and the proposed clinical study(ies):
    A brief description of the stability study and the test methods used to monitor the stability of the drug substance should be submitted. Preliminary tabular data based on representative material may be submitted. Neither detailed stability data nor the stability protocol should be submitted.

    --

    I am assuming that there is some DS stability data available. If so, add that to the IND and indicate that as development progresses, additional data will be submitted (and if there are any OOO spec results, then the Agency will be notified). In the US, there is no need to claim DS expiry.

    Hope this helpful!

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    Jessica Kokosinski
    VP Regulatory Affairs
    Warren NJ
    United States
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    Original Message


  • 3.  RE: How much DS stability data is required for an IND?

    Posted 26-Jul-2019 09:58
    ​I agree with Jessica. There is no minimum amount required - just submit whatever you have. Especially since the agency seems to be allowing very little data on the DP, there's no reason to think they would be more conservative for the DS.

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    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
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    Original Message


  • 4.  RE: How much DS stability data is required for an IND?

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jul-2019 12:54
    This message was posted by a user wishing to remain anonymous

    You need enough stability to support the length of time between manufacture of DS and when you use it in DP. For instance, if you manufacture the DS then store it for 2 months before manufacturing the DP, you will need at least 2 months. But other than that, I agree with the others that there is no specific length of time you need at the IND stage.
    Original Message


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