Accelerated screening and orientation sensitive chromatographic modeling of biopharmaceuticals

The downstream process development for biopharmaceuticals is faced with increasing challenges. A growing market of drug candidates and new molecule families, as well as a rising trend to personalized medicine lead to an increase in market diversity. At the same time more purification techniques and materials become available, resulting in an exponential growth in potential parameter combinations and conditions to be considered and screened for. The establishment of high throughput screening (HTS) technologies and automated liquid handling stations (LHS) have driven standardization in experiments, data handling and data quality assessment in the last decade. Despite, the establishment of automation technologies for almost all purification process steps throughout the field of DSP development, a miniaturization beyond the scale of 96-well plates has not been reached, as sample handling and pipetting accuracy fell short with established LHS...