Regulatory Open Forum

 View Only

  • 1.  Notified Body Opinion and Stability data for iDDC

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2024 09:08
    This message was posted by a user wishing to remain anonymous

    Dear Regulatory experts,

    I work in a biotech company and I prepare our regulatory strategy for a new combination product (mAbs pre-filled in syringe with an auto-injector, sold as a single integral product).

    I kindly request your support on how optimizing the timelines of submission/review versus the generation of stability data for Europe.

    For the Notified Body Opinion submission, may I submit:

    - on filled product (drug in syringe): limited data, for example 3-month real time stability data, (with 3 time points: 0, 1 and 3 months) and accelerated stability data?  I would then have time during the NB review to generate more stability data on my drug, that will be reviewed by EMA afterwards.

    - on syringe and auto-injector: Leverage only stability data from suppliers to support the shelf-life of the components? Or should I have at least data with my syringe in an auto-injector which went unde accelerated stability studies.

    Thanking you in advance for your experience sharing,

    With my kindest regards,



  • 2.  RE: Notified Body Opinion and Stability data for iDDC

    Posted 23-Feb-2024 06:10

    Anon,

    Generally speaking (without regard to your specific Notified Body or reviewer, who may have more particular expectations):

    • Note that the NBOp will be concerned with the functionality of the device (part), not necessarily the drug product stability (which will be subject to EMA review). Sometimes these data are combined within the same stability study (and included in 3.2.P.8 of the MAA), though for the NBOp one may want to pull out the device-related data in case they are combined.
    • Generally, data should be supportive of the established shelf life which could conceptually include a combination of accelerated and real-time data. If real-time data is limited, the real-time equivalent data as calculated from accelerated conditions (using something like ASTM F1980) should support the desired shelf life. I have seen this accepted, but one should have sufficient data (potentially from prior development studies or another similar product) to demonstrate that the accelerated data is representative.
    • Typically, the data should be expected to be in the format of concern (i.e. the actual drug product in the pre-filled syringe and auto-injector) - in the US, this is unavoidable given FDA's stance on the matter, however other regulators may be more forgiving (but your experience may vary).
      • Note that the drug product's fluid properties (volume, viscosity in particular), the selected primary container components (syringe, needle gauge, plunger), and process parameters (particularly fill-finish operations) are likely to impact the functional performance in some manner, so I would highly encourage collecting data for the auto-injector using the actual drug product.

    Hope that helps as an initial pass - though details of your situation may be pertinent to the conclusion. Feel free to reach out directly via DM if you would like to discuss further. Best of luck!



    ------------------------------
    Jonathan Amaya-Hodges
    Director, Technical Services
    Suttons Creek, Inc.
    United States
    jamaya-hodges@suttonscreek.com
    ------------------------------

    Original Message


Related Content