Streamline Analytical Tech Transfer Through ATP Diligence And Standardization

By Kitman Yeung, Mitenyi Biotec

Every assay shipped from the analytical development lab carries invisible “analytics debt.” A couple of clean replicates and a tidy R² may satisfy discovery timelines, but the first time that method lands in a GMP suite, the interest comes due in the form of repeat robustness runs, gating-template drift, and 30-day FDA queries that nobody budgeted.

The single most effective way to erase that debt is to draft the Analytical Target Profile (ATP) before the first antibody lot is ordered — and to lock hardware, software, and reagents into a common platform on day one. Additionally, analytical tech transfer succeeds only with staff fluent in ICH-level assay validation, applying the proper tools to answer the right questions. This can be accomplished by a two-pronged approach: invest in targeted training for your existing team, and fill remaining gaps by partnering with a CDMO whose analytical science and technology (ASAT) group can ‘parachute in’ proven people and platforms.