Hi BioQC users!
I am curious about your experiences, both positive and negative, in implementing an Analytical Target Profile within your companies. How was it received, does it work, does it make your life easier? Thanks!
"The implementation of the Analytical Target Profile (ATP) within the company involved several important aspects. Initially, the ATP served as a tool for other departments to flag the need for new assays. However, both the process and product development departments struggled to define the required assay performance characteristics. Additionally, projects often revealed a need for new assays, but project managers were unclear about how to formally request method development.
To address this, we decided to put analytical scientists in the lead. They proactively identified assay needs and translated result requirements into analytical specifications. However, this shift brought its own challenges—many analytical scientists found it difficult to perform these translations and needed training in both effective communication and statistical reasoning.
Ultimately, by training a few analytical scientists thoroughly and positioning them as ATP leads, we established a highly effective and streamlined process flow."
Learn more from Dr. Lars Geurink by viewing his presentation "Analytical Procedure Control Strategy (ACPS)" during the Expert Forum: Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development
I fully underline the previous answer, and you can also bring it back to a simpler question: if you do not know what the purpose of the method will be, how do you know what to develop and when the development is ready and the method fit-for-purpose?
Even if the term Analytical Target Profile is not being used, the analytical scientists do need the answer to these fundamental questions before they can do their job properly. The publication of ICH Q14 supports this further, and as one can learn from the discussions we had, the use of an ATP can help to streamline getting the information the analytical scientist needs.
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