Molnár-Institute showcasing powerful new modeling technologies at HPLC 2019 Milan

Berlin: – Molnár-Institute for Applied Chromatography will be a prominent presence at the 2019 International Symposium on High Performance Liquid Phase Separations, held from June 16^th-20^th in Milan, Italy. There, Molnár-Institute will contribute to the scientific agenda and have their own booth as an exhibitor.

At booth 41 in Hall U6-06 at Milan’s Bicocca University, the team around Dr. Imre Molnár will present its leading-edge training courses and powerful DryLab^®4 separation modeling software that designs efficiency and success in any high-performance liquid chromatography (HPLC) method through the most advanced approach.

Lifecycle-oriented method development

Molnár-Institute will also contribute an oral lecture and stage a vendor seminar at the symposium.

In their lecture, «Advantages of a lifecycle-oriented, analytical method development approach in the pharmaceutical industry», the institute’s founder and President, Dr. Imre Molnár, and Arnold Zöldhegyi, MSc., will show why current «one-off» method development strategies fail to meet the challenges of the ever-increasing complexity of pharmaceutical analysis that comes along with a rising demand for multi-API drugs and therapeutic proteins such as mAbs and ADCs.

Recent regulatory changes now introduce the concept of post approval change management protocols (PACMP) and apply ICH proposed lifecycle perspectives to grant more leeway for science-based, flexible changes to be managed within the design space. This fosters a chromatographic retention modeling based on sound scientific theory that methodically substantiates the interdependencies of method parameters.

The lecture will show how a lifecycle oriented, analytical method development approach models the in-routine variation of parameters caused by varying instrument measurement accuracy, performing robustness modeling at the earliest possible stage (stage 1), in accordance with recent regulatory guidelines. The practical advantages of applying the lifecycle approach to analytical method development will be demonstrated using case studies.

Automated UHPLC modeling

Dr. Molnár and Arnold Zöldhegyi will also present the institute’s vendor seminar at HPLC 2019 Milan: «Automated UHPLC method modeling: A step towards innovative chromatographic data generation and analysis», showing how automated routines in retention modeling can provide powerful tools to mitigate human error, increase productivity and reduce costs per analysis.

The seminar will feature a successfully automated method development workflow on industrial Cannabis sativa sample – including separation modeling of four main peaks of interest (CBD, CDBA, THC and THCA) and 10 additional compounds. Automation is possible throught the seamless integration of DryLab^®4 software to Waters Empower chromatographic data system on multiple levels: batch creation and acquisition of inputs required for a 3D Design Space, model and setpoint verifications and experimental confirmation of the model’s robustness.

Powerful 3D-perspectives on design space that visualize interdependencies of flowrate and gradient properties can yield extended gradient time-temperature models for practical definition of robust methods and transparent regulatory filings.

It will also report on Molnar-Institute’s introduction of a new general chromatography data format, the so called dlproj-format, that includes up to 12 input chromatograms, column and instrument conditions, peak tracking and robustness calculations, all summarized in a QbD-relevant Knowledge Management Document for fast regulatory approval of new drugs.

About Molnar-Institute

Molnár-Institute for applied chromatography focuses on new strategies for improving the efficiency and success of modern high-performance liquid chromatography (HPLC) through its method development software DryLab^®4, HPLC software training courses and consulting. Since its foundation in 1981, by Dr. Imre Molnár in Berlin, Molnár-Institute is following a consistent mission to form a center of excellence to save, reduce and optimize method development and run time in HPLC.

The institute supports ongoing research and development at universities and corporations worldwide with a team of By applying its proprietary method development software DryLab^®4 in conjunction with rigorous methodologies, the institute is able to optimize method development and reduce method run time in HPLC and UHPLC. Using real data from a small number of experimental runs, DryLab^®4 builds multi-dimensional selectivity maps depicting the interaction of the most important parameters influencing an HPLC separation. This systematic, guided method development process can halve development time, help users optimize parameters based on their specific method goals, and enable easier compliance with regulatory standards (QbD).

Dr. Imre Molnár remains president of the Molnar-Institute, which is a privately-owned organisation, headquartered in central Berlin.

About HPLC 2019

The International Symposium on High Performance Liquid Phase Separations (HPLC) is an international scientific forum focusing on high-performance liquid chromatography in its various forms, along with complementary separation techniques such as electrophoresis, electrochromatography, field-flow fractionation, supercritical fluid chromatography and hyphenated techniques, such as LC/MS, CE/MS and SFC/MS. Then conference also considers microfluidic, nanofluidic and chip separations, diagnostic systems, and other leading technologies.

Founded in 1973, the annual symposium alternates between venues in Europe and the USA, with the 2018 conference held in Washington DC. Every European meeting is accompanied by a supplementary symposium held in Asia or Australasia.

The 48^th Symposium, HPLC 2019, is a five-day event opening June 16 at the University of Milano-Bicocca in Milan, Italy.

The event is organized by Effetti srl, with more information at: https://www.hplc2019-milan.org/