Streamline Analytical Tech Transfer Through Analytical Target Profile (ATP) Diligence And Standardization

By Kitman Yeung, Mitenyi Biotec

In cell and gene therapy (CGT), the cost of overlooking analytical rigor during early development can be steep. What seems sufficient in discovery—clean replicates and strong R² values—can unravel in GMP environments, triggering delays, unexpected FDA queries, and budget overruns. This case study introduces the concept of “analytics debt” and offers a practical framework for avoiding it altogether. With insights drawn from over 20 years in analytical development and tech transfer, the author emphasizes the importance of drafting an Analytical Target Profile (ATP) before any reagents are ordered. By aligning AD, ASAT, and QC teams from the outset and standardizing tools and workflows, organizations can streamline tech transfer and ensure smoother regulatory submissions. The result? Fewer CAPAs, faster IND approvals, and a more resilient CGT pipeline.

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