Waters has now associated itself with S-Matrix Corporation, a developer of advanced software to automate R & D experimental work according to Quality by Design principles and methods. Currently regulatory bodies are emphasizing more and more on Quality by Design in pharmaceutical development. Working with S-Matrix would help Waters to unveil a complete LC Chromatographic Method Development solution.

The LC Method Development system provides an integrated and automated, Quality by Design method development solution, that reduces the amount of time that it takes to develop a method. The approach ensures that a robust, fit-for-purpose method is developed. Developing quality methods the first time allows for problem-free validation, transfer and operation, thereby eliminating the time and cost associated with having to redevelop and revalidate chromatographic methods.

The solution includes the superior chromatographic performance of Waters Acquity UPLC system, and the industry-leading chromatography data software, Empower 2, with S-Matrix Fusion Method Development software.

The focus in the pharmaceutical industry today is on shortening drug development times while reducing operating costs. Incorporating Quality by Design principles in the pharmaceutical development process not only leads to more robust methods, but it also helps to achieve the necessary productivity improvements and cost reductions, Chandresh Jain, AGM - Informatics, Waters India told Pharmabiz in an email interaction.

According to the  ICH guidance document the  aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space, specifications, and manufacturing controls. Information from pharmaceutical development studies can be a basis for quality risk management. Therefore it is important to recognize that quality cannot be tested into products and that quality should be built in by design.

Fusion Method Development automatically builds and runs experiments that screen multiple columns and mobile phases and optimizes LC methods using standard or user-customized templates. Incorporating a systematic Quality-by-Design approach, Fusion Method Development automatically selects the most efficient statistical design that defines the QbD knowledge space. With one click, Fusion Method Development transfers the experimental design to Empower 2 as ready-to-run methods and sample sets, informed Jain.

The processed results in Empower 2 are imported into Fusion Method Development software. It then analyses and models critical method performance characteristics easily. Response surface plots show the combined effects of variables on key chromatographic responses such as peak resolution, tailing, and retention. Colour gradation represents the magnitude of interactions with curvature indicating the type of interaction. Chromatographic data are used to generate parameter-effect models which are displayed numerically using the Automated Optimizer and graphically as Overlay graphs for easy interpretation. Fusion Method Development overlay graphs predict mean method performance and robustness. “Since the optimized method proposed by Fusion is based on models of experimental data collected, and not simulations, it is expected that the predicted method compares favourably with the actual final chromatographic result,” stated Jain.