MOLNÁR-INSTITUTE highlighting Design Space Methodology at ISSS 2023 Romania

Berlin: – The Molnár-Institute for Applied Chromatography will again take a prominent role at the upcoming 27th International Symposium on Separation Sciences (ISSS 2023) at Cluj-Napoca in Romania, both as a leading sponsor and keynote scientific contributor.

The Institute is sponsoring the event under the banner of its industry leading DryLab® separations modeling platform, with two of its scientists addressing the symposium.

History and Present of HPLC Modelling

The Institute’s founder and President, Dr. Imre Molnár, will give a keynote presentation on ‘The History of HPLC Modeling’ that will trace the development of High-Performance Liquid Chromatography (HPLC) enhanced by 2D and 3D modelling of HPLC separations for modern pharmaceutical analysis. He will also give a short retrospective overview on the 60 years path of HPLC, starting from building the first HPLC device in Csaba Horváth’s Mason Laboratory, to current establishment of powerful computer systems in efficient modeling HPLC—the basic principles that were laid down by renown separation scientists, including Lloyd Snyder, John Dolan and others.

These advances resulted in fully digitalized pharmaceutical networks supporting faster development of new drug entities that are revolutionizing today Life Science areas. The presentation will also cover the ongoing paradigm shift in the industry, embraced by Quality by Design (QbD) standards to the creation of 3D Design Spaces (DSs), Method Operable Design Region (MODR), robustness terms, and Multiple Attribute Modelling (MAM), all of which have plated their parts in revolutionizing the speed, accuracy and range of method development.

Stepping forward with the Application of Design Space Models

The contribution of multidimensional computerized design spaces in enhancing understanding of complex chromatographic interdependencies with minimized experimental work is also the focus of the second Molnár-Institute presentation to the ISSS, from its Senior Scientist, Arnold Zöldhegyi. His presentation ‘Applied Design Space Models: Industry Examples of a common, Multidimensional platform approach that characterizes and compares HPLC Separation Systems’ discusses various applications of multidimensional DS models in pharmaceutical R&D, including real-world examples that highlight their benefits and practical potential for accelerating development.

By showing several case studies, he will also illustrate the versatility and power of multidimensional DS models in enhancing understanding and facilitating informed decision-making in analytical procedure development. In particular, adopting a platform approach to the multidimensional DS can unlock valuable insights that enable researchers to characterize and compare separations more effectively and optimize their HPLC methods for improved analytical outcomes.

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 Analytical Quality by Design (AQbD) principles, according to the recently published ICH Q14 regulatory framework.

The Molnár-Institute is a registered partner of the US-FDA, CDC and many other regulatory bodies. DryLab®4 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 ISSS 2023

The International Symposium on Separation Sciences is an annual conference for researchers and practitioners in liquid and gaseous phase chromatography as well as capillary electro migration separation techniques.

The symposium covers new advances and challenges in all fields of separation sciences and hyphenated techniques, providing a platform for young scientists as well as renowned researchers and industrial partners to exchange opinions, introduce new methods and acquire new practical knowledge.

The 27^th ISSS 2023 Symposium will be a four-day event opening September 24 at the Univers T Hotel on the shores of Lake Gheorgeni near the historic city of Cluj.

The ISSS 2023 program will focus on fundamental and practical aspects of separation and detection methods as well as hyphenated, multidimensional and miniaturized separation techniques applied for analytical, preparative and industrial purposes,

The event is organized by the Romanian Chemical Society with further information at: https://isss2023.conference.ubbcluj.ro

Resources

Click on Molnár-Institute Method Development Services for other information.