Assisted Active Learning for Model-Based Method Development in Liquid Chromatography.

In recent decades, there has been a growing interest in fully automated methods for tackling complex optimization problems across various fields. Active learning (AL) and its variant, assisted active learning (AAL), incorporating guidance or assistance from external sources into the learning process, play key roles in this automation by enabling the autonomous selection of optimal experimental conditions to efficiently explore the problem space. These approaches are particularly valuable in situations wherein experimentation is costly or time-consuming.

Application of design space and quality by design methodologies combined with ultra high-performance liquid chromatography for the optimization of the sample preparation of complex pharmaceutical dosage forms.

Accurate and precise analytical measurements play a significant role in assessments and decisions that are made throughout the drug development process. Developing a robust and reliable sample preparation is essential for drug product formulations to generate consistent results guaranteeing the product quality. However, due to the complex nature of the different pharmaceutical formulations with diverse excipients, developing robust sample preparation methods can be challenging and time consuming.

Development of an achiral-chiral 2-dimensional heart-cutting platform for enhanced pharmaceutical impurity analysis.

A new broadly applicable achiral-chiral 2-dimensional heart-cutting (LC-LC) platform is designed comprising a multi-column selection approach in the chiral dimension. As both dimensions are operated in a highly aqueous reversed-phase type mode, analysis of a broad range of pharmaceutical solutes (LogP: 1.49-5.

Model-based NIR spectroscopy implementation for in-line assay monitoring during a pharmaceutical suspension manufacturing process.

The implementation of Process Analytical Technology (PAT) instruments is generally achieved stochastically. Sub-optimal PAT locations could introduce variation in the measurements which is not related to the analyte of interest. For this reason, rational approaches should be considered to establish an optimal sensor placement where relevant measurements are possible and the impact of disturbances is minimized.

In-line UV spectroscopy for the quantification of low-dose active ingredients during the manufacturing of pharmaceutical semi-solid and liquid formulations.

UltraViolet (UV) spectroscopy was evaluated as an innovative Process Analytical Technology (PAT) - tool for the in-line and real-time quantitative determination of low-dosed active pharmaceutical ingredients (APIs) in a semi-solid (gel) and a liquid (suspension) pharmaceutical formulation during their batch production process. The performance of this new PAT-tool (i.e.