Robust by Design: Method Development Through Commercial QC

Poster Authors: Alice Harmer, Anna Zhalnina, Sophie Strickfuss Pharmaron, Hoddesdon, UK Download Poster: Connecting Method Development to Commercial QC Developing analytical methods with the end user in mind can reduce transfer risk and accelerate implementation at commercial testing sites. In this poster, Pharmaron demonstrates how computational modelling and analytical Quality by Design (aQbD) principles were used to develop a robust achiral HPLC method that met Commercial QC requirements from the earliest stages of development. The approach combined method optimisation, robustness assessment and QC-focused verification to support reliable performance throughout the method lifecycle. Key Takeaways This poster highlights how early application of computational modelling and aQbD principles can strengthen method robustness and improve readiness for Commercial QC. By evaluating critical method parameters during development and aligning verification activities with receiving laboratory expectations, potential transfer risks were identified and addressed before implementation. The result was a fit-for-purpose analytical method designed to support long-term QC use.

Poster Authors:

Alice Harmer, Anna Zhalnina, Sophie Strickfuss

Pharmaron, Hoddesdon, UK

Download Poster: Connecting Method Development to Commercial QC

Developing analytical methods with the end user in mind can reduce transfer risk and accelerate implementation at commercial testing sites. In this poster, Pharmaron demonstrates how computational modelling and analytical Quality by Design (aQbD) principles were used to develop a robust achiral HPLC method that met Commercial QC requirements from the earliest stages of development. The approach combined method optimisation, robustness assessment and QC-focused verification to support reliable performance throughout the method lifecycle.

Key Takeaways

This poster highlights how early application of computational modelling and aQbD principles can strengthen method robustness and improve readiness for Commercial QC. By evaluating critical method parameters during development and aligning verification activities with receiving laboratory expectations, potential transfer risks were identified and addressed before implementation. The result was a fit-for-purpose analytical method designed to support long-term QC use.

Capabilities

Knowledge Center
Chemistry, Manufacturing & Controls
Analytical Development and Quality Control
Connect with a Scientific Expert

Key Results

Computational modelling enabled rapid exploration of method space and identified operating conditions that delivered robust peak resolution. A 3D design space model demonstrated the impact of pH, gradient and temperature on method performance, allowing optimal conditions to be selected with confidence. Verification studies confirmed the method met Commercial QC requirements for accuracy, precision, specificity, sensitivity and linearity, while spike recovery assessments supported reliable impurity quantification and successful method transfer.

Why Pharmaron?

Pharmaron provides integrated analytical development and quality control expertise across a global network of sites in the UK, China and the US. Our teams support the complete analytical lifecycle, from early method development through validation, transfer and Commercial QC implementation. By combining scientific expertise, advanced digital tools and deep regulatory understanding, we help clients develop robust, scalable methods that are ready for routine QC use from day one.