Molnár-Institute offers courses on the application of the DryLab software for efficient high-performance liquid chromatography (HPLC) method development.
The company’s courses are taught by Dr Imre Molnár, Dr Hans-Jürgen Rieger, and guest lecturer Alexander H Schmidt (founder and president of Chromicent), which each bring in-depth knowledge and experience to the classroom in both theory and practice of HPLC.
Courses are taught in English regularly throughout the year in Berlin, Germany, and the company also offers in-house courses in English or German at company locations worldwide.
Intensive DryLab®4 Training for UHPLC Method Development – 3 Days
This course provides extensive training for the UHPLC method development by modelling under the use of the software DryLab4.
Course participants are guided through a comprehensive method development process, starting with basic one-dimensional model calculations and continuing through multi-dimensional (3D) model optimisations.
Users learn to develop, adjust, transfer, and improve methods, focusing on decreasing run times while maintaining the desired selectivity. Furthermore, the course teaches participants to systematically develop robust methods with DryLab4 by creating multidimensional models depicting the interaction of up to twelve of influential HPLC parameters, resulting in better communication with regulatory agencies and faster market entry for new drugs.
A part of this course is devoted to the topic quality by design (QbD) in ultra-high performance liquid chromatography (UHPLC) method development. UHPLC users want to understand the QbD framework and how it relates to UHPLC method development processes, especially in regards to the submission of new drug applications.
Analytical QbD is a modern concept for assuring the quality of a product and is recommended by regulatory authorities like the US Food and Drug Administration (FDA).
The QbD approach requires a systematic study of the most important factors influencing the quality of a product, and can be successfully adopted into UHPLC method development using DryLab4 software. The course focuses on new approaches for visualising the so-called ‘design space’, with the goal of gaining more flexibility in routine HPLC applications.
Method Development for the Separation of Therapeutic Proteins (Biopolymers) – 2 Days
This course gives an extensive training on the UHPLC method development for the separation of therapeutic proteins. The fundamentals of reversed-phase (RP), ion-exchange (IEX), hydrophobic interaction (HI) and size-exclusion (SE) chromatography are explained and discussed. Several examples on monoclonal antibodies (mAbs) and related products, such as antibody-drug conjugates (ADCs) are presented.
MAbs and related therapeutics currently account for global sales of more than $50bn and are starting to receive competition from biosimilar incomes. Most pharmaceutical companies have entered the rapidly growing biosimilar market. Therefore, the appropriate and detailed analysis of biopharmaceuticals at different levels (top-down, middle-down and bottom-up) is demanded by the authorities.
Participants will learn the different two and three-dimensional (3D) optimisation models for all the above mentioned chromatographic modes. Fast and efficient method adjustment, transfer and robustness testing are also demonstrated.