The Critical Reagents sub will not meet again until Jan 2025, however in the mean time have had questions from one of sub team members (@Christopher Sucato) who wanted to get a discussion going about how to handle recharacterization of regents through out its life cycle. Please discuss in this thread if you have anything you would like to contribute to the discussion. Please see the bullet points below for Chris' questions and comments.
- Our CR Group oversees a large number of protein critical reagents that are used in drug dev projects that may have a long lifetime.
- We issue COAs for the reagents and have to re-QC them periodically (annually or every 6 mo, etc).
- Sometimes there is a small or modest change in the concentration we measure for the reagent (usu by A280).
- When we issue a new COA for the reagent, with the new concentration, the change affects the downstream assays (LBAs for example).
- Our partners who do the LBAs, or other downstream tests, claim that the change in concentration is burdensome given they have precise steps to follow, wherein the CR concentration is 'hard-coded' into the procedure. They would rather keep using the older reported concentration value as long as the numbers (old vs. new) are fairly close.
- But we take steps to make sure our concentration assay is accurate, precise, robust, etc, so we have good confidence in the new concentration numbers we are getting.
- How should a CR Group handle this issue? Any experience from other groups out there?
Hope you all have a great end of the year, look forward to what the new year brings!
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Scott Robotham, Ph.D.
Principal Scientist
Bristol Myers Squibb
Princeton, NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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