MOLNÁR-INSTITUTE to present new enhanced chromatography modelling technique at “ISC 2022” in Budapest, 18. – 22.09.2022

Berlin: – Molnár-Institute for Applied Chromatography will return to ISC 2022 international symposium for chromatography with powerful enhancements to its DryLab^®4 automation and advanced HPLC modelling software.

Molnár-Institute will be an exhibitor at this great international HPLC event, with a stand showcasing its DryLab®4 chromatography modelling platform, including advanced features, like the “Design Space Comparison Module” (DSCM), that provides easy solutions for a holistic comparison of various separation systems, such as different columns, instruments, methods, etc. The display will also feature the institute’s other capabilities in analysis, chromatography, biotechnology, biocomputing, and software for quality assessment, statistics and visualization.

AQbD model-based comparison

The Molnár team will contribute this year’s ISC scientific program an oral presentation on ‘Analytical Quality-by-Design (AQbD) model-based comparison of HPLC-Separation Systems using multivariate eluent Design Spaces’.

Arnold Zöldhegyi, DryLab’s software application specialist, will demonstrate new scientific results of continuous collaboration between academia and industry – George Emil Palade University in Targu Mures and Sz-imfidum Ltd. – on a recent study that established a streamlined, model-based characterization and comparison of complete separation systems.

Finding equivalent and replacement columns

The study sought to develop a method to identify backup- or replacement-HPLC-columns with similar selectivities for the developed method in case, when the primary chosen stationary phase becomes unavailable due to discontinued production, supply chain issues, etc.

The oral lecture will illustrate key advantages – with the main highlight on employing systematic development strategies, along with chromatography-based modeling tools – to achieve consistent method design that can effectively replace trial-and-error, one-factor-at-a-time and other, less efficient method development strategies in finding the most attractive stationary phase and method parameter combination for a specific separation problem.

Furthermore, the proposed modelling strategies are completely in line with the latest AQbD (draft) guidelines (ICH-Q14 and Q2-(R2)) and the lifecycle-management chapter (ICH Q12) that set new industry standards to analytical procedure development by urging HPLC-specialists to follow ‘enhanced’ modelling approaches to build a science-driven, risk-, and knowledge-based development routine that also facilitate transition from the earlier fixed setpoint concept towards more flexible Method Operable Design Region (MODR).

Multiple 3D Design Spaces

The research team, led by Prof. Dr. Zoltán Szabó, Elek Ferencz, and Arnold Zöldhegyi, used DryLab®4 chromatography-based modeling software to build 3D-separation models of Ezetimibe and its related substances on 9 different Reversed-Phase HPLC-columns, with acquired multivariate Eluent Design Spaces (EDS), providing in-depth characterization of each separation system, complying with Analytical-Quality-by-Design (AQbD) methodology. The team used the acquired unique models of Design Spaces of each individual separation units to identify both dissimilar and interchangeable areas in their MODR’s. Advanced multi-attribute modeling options of the software allowed the team to pinpoint optimum setpoints for each separation system and customize method goals by considering concurrent fulfillments of multiple method-specific criteria, such as resolution, runtime, and peak-shape.

The overall result was a proof-of-concept experimentally verified on all nine modeled separation systems.

About MOLNÁR-INSTITUTE

Founded in 1981, Molnár-Institute develops DryLab®4, a software for UHPLC modelling for a world-wide market. Its powerful modules gradient editor, peak tracking, automation, robustness and Design Space Comparison allow for the most sophisticated method development as required across modern pharma industries. Analytical scientists use DryLab®4 to understand chromatographic interactions, to reduce analysis time, to increase robustness, and to conform to AQbD-principles, according to the recently published ICH Q14 regulatory framework.

The Molnár-Institute is a registered partner to the US-FDA, CDC and many other regulatory bodies. DryLab®4 has pioneered AQbD long before regulatory agencies across the world encouraged such submissions. Widely implemented by thought leaders, the software contributes substantially to the paradigm shift towards a science and risk driven perspective on HPLC Quality Control and Assurance.

Further information at: http://www.molnar-institute.com/

About ISC 2022

First held in 1956, the biennial International Symposium on Chromatography (ISC) represents the longest standing conference series on Separation Science and now represents one of the world’s foremost forums for discussion of all modes of chromatography and separation with a broad coverage of techniques and applications.

The 33^rd Symposium, ISC 2022, is a five-day-event, opening September 18, at the Novotel in central Budapest.

The major focus of the 2022 symposium will be on the impact of chromatography and separation sciences in meeting the needs of the pharmaceutical, environmental, food and health industries.

The scientific programme of lectures and poster sessions will be accompanied by an international exhibition and vendor seminars on instrumentation and services for chromatography, separation sciences and mass spectrometry.

The event is organized by Diamond Congress for the Hungarian Society for Separation Sciences, with further details at https://isc2022.hu

Resources

Click on ISC 2022 Conference  to download conference program.