In my experience a Certificate of Testing has very little utility except for contract labs to confirm they performed certain tests. I have seldom seen results on a CoT; they usually refer you to the CoA for the results. I must say I am puzzled by the reluctance to put potency on the CoA. For phase 1 the FDA does not expect you to have anything validated. Qualified - yes, validated - no. But they DO expect yo to have potency.
If you are having difficulty with your potency assay you have options. You can find a lab or consultant specializing in method development to assist you; you can try adding another potency assay while you work out the bugs in the first one, thus creating a "Plan B" option. Most of the projects I work on have two potency assays - an ELISA-based one and a cell-based assay. While regulators will accept a single potency assay, they prefer to see two potency assays for a given product.
Don't outsmart yourself. Put the potency assay and results on the CoA and provide any necessary explanations to the agency either in a pre-meeting briefing book or in the IND. Generally speaking, the FDA likes to help with problematic assays.
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Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United States
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Original Message:
Sent: 02-May-2023 08:49
From: Anonymous Member
Subject: Potency assay: a characterization assay instead of a release assay?
This message was posted by a user wishing to remain anonymous
What is certificate of testing???? For IND, the potency assay results must be part of release testing (for clinical trial) document even if the assay is not validated! See above the response from Anon!
Original Message:
Sent: 01-May-2023 09:50
From: Anonymous Member
Subject: Potency assay: a characterization assay instead of a release assay?
This message was posted by a user wishing to remain anonymous
Thank you for your responses. we are working on a few orthogonal potency assays, and haven't decided on which one we will qualify and use for release.
1. Is it OK for potency assays to be reported on a certificate of testing, separate from the CoA?
2. is it ok if we keep all potency assays as characterization assays only (not as release assays) until phase 2?
Thanks!
Original Message:
Sent: 25-Apr-2023 09:53
From: Anonymous Member
Subject: Potency assay: a characterization assay instead of a release assay?
This message was posted by a user wishing to remain anonymous
For a phase 1 IND, fully developed release assay is fine, doesn't need to be validated! Assay results using the fully developed assay must be part of the COA.
Both assay and impurity profile are equally critical and must be reported on COA even if they are not validated!
Original Message:
Sent: 23-Apr-2023 09:31
From: Anonymous Member
Subject: Potency assay: a characterization assay instead of a release assay?
This message was posted by a user wishing to remain anonymous
Hello colleagues,
My company is working on an enzyme for therapeutic use (in vivo and ex vivo applications). We plan to file an IND within the next 2 years, however the potency assay to be used for measuring enzyme activity is still under development. I have several questions:
1. What impact will it have on the IND application if we have the potency assay fully developed but not qualified before the first GMP product release and before IND application?
2. Do we need to keep the potency assay off the Certificate of analysis and specification document until the assay is qualified? We are not comfortable setting a specification for this assay yet.
3. Can we keep the potency assay as a characterization assay (not release assay) until after the first GMP production? The intent is to qualify the assay only after the first GMP production.
As a longer term strategy, we plan to have the potency assay qualified before phase 2 clinical trial.
Looking forward to hearing from you. Thank you.