White Paper
The CGT Analytics Maze
CGT analytics isn't a linear checklist — it's a decision tree where every answer creates new questions.
What the Framework Reveals
Why you can't plan your full analytical testing schedule in advance
3
foundational lessons for navigating CGT analytics complexity
0
the number of pre-determined checklists that actually work here
1
central insight: each result reshapes the next question
A CGT developer can't map out their full analytical testing schedule months in advance, because each "proof point" directly reshapes what has to be investigated next — a purity measurement might reveal an unexpected impurity, triggering a whole new characterization branch. This paper is a direct result of MKA's own deep-dive review of FDA guidance and industry sources, mapping the decision-tree structure that CGT teams are actually navigating, whether or not they've named it.
Source: Pages TBD · Jan 2026 · MKA-18-WP, Executive Summary
Built for: CGT leaders and analysts assessing analytical strategy.