Analytical Target Profiles and Method Development in ICH Q14: A Panel Discussion on Best Practices

This summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists for their time and expertise.

Developing analytical methods for biopharmaceuticals requires far more than selecting an instrument and running an analysis. It demands a comprehensive strategy that connects product quality directly to analytical performance. An expert panel of analytical scientists from industry and academia explored one of the most critical yet frequently misunderstood aspects of the ICH Q14 guideline: the analytical target profile (ATP). The discussion reveals that effective implementation requires collaboration across disciplines, clear communication, and a fundamental shift in how organisations approach method development.

Who Decides on the Analytical Target Profile?

The question of who determines an analytical target profile proves deceptively complex. While the analytical researcher typically leads this effort, the decision is fundamentally shaped by

the intended application of the method and the product’s quality target profile. Importantly, the client – meaning those who will ultimately run the method and use the data – must participate meaningfully in this process.

The client in this context is not necessarily an external party. Rather, it represents the person or group who will execute the method and depend on its results. This might include quality control personnel, process development scientists building manufacturing knowledge, or control strategy teams designing quality assurance systems.

Their input is essential because they understand the real-world constraints and requirements that the method must meet.

For instance, when defining acceptable variability for a test, different stakeholders may have vastly different perspectives based on their specific needs, and reconciling these views upfront prevents costly misalignment later.

The Importance of Working Across Disciplines

A dominant theme throughout the discussion was the power of bringing together scientists from different backgrounds. Method development succeeds best when analytical scientists, process specialists, and quality teams work as an integrated unit rather than in silos. This means involving analytical expertise not just at the end of development, but throughout discussions about critical process parameters and quality attributes.

One key challenge is language translation. Process scientists and analytical scientists often think about problems differently and use different terminology.

When these groups collaborate intentionally, they must learn to translate between their perspectives.

This communication effort, while requiring investment upfront, prevents fundamental misunderstandings that otherwise emerge during late-stage troubleshooting. The analytical scientist should lead the ATP development process, but only after meaningful cross-functional dialogue has occurred.

ATPs Can Change – And Sometimes Should

As method development progresses, the analytical target profile may need adjustment based on experimental results. This is not a failure but rather a natural part of the iterative process. Changes to performance criteria are acceptable, though the overall aim of the method should remain constant.

A common scenario illustrates this challenge: early in development, organisations often set variability requirements that are unrealistically tight. Without clear information about what the method truly needs to achieve, teams tend to over-specify. This happens frequently when stakeholders, wanting to be cautious, request extremely low variability when something less stringent would be perfectly adequate for the intended purpose. The analytical scientist plays a crucial role in pushing back against over-specification, using scientific reasoning to justify why less stringent criteria are still fit for purpose.

When an ATP does require modification, this change must be evaluated bidirectionally. Backward-looking review examines impacts on product quality targets and the overall control strategy.

Forward-looking review assesses implications for method development path and testing requirements. This discipline ensures that ATP changes remain scientifically justified and don’t inadvertently compromise product quality.

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