From discovery to production with the same chromatographic partner across the board

When a project starts in research and development small UHPLC/ HPLC columns with particles between 1.8 and 3.5 µm are used to effectively and efficiently work in the discovery of new drugs and natural compounds. Then we suggest transferring the resulting method to a 4.6 mm ID column, or possibly 10 mm ID, under overloading conditions, if larger sample fractions are needed to characterise the substances of interest. Bigger particles are frequently employed in purification since the efficiency and back pressure will then be close to the large scale separation. A small column will make the development work easier, and since the performance is identical in small and large diameter columns, the result in large scale can easily be predicted from the work in the small scale. For large scale preparative chromatography, 10 µm particles and above are usually good choices. Independently, the performance using a different particle size can easily be predicted.

The example shown here consists in the purification of fish oil esters going from an analytical run to a small scale purification using a traditional Kromasil 100 Å, 10 µm, C18, 4.6 x 250 mm, a particle size that can be used even in production. The same application is also done with a 21.2 x 250 mm column. Note the seamless scale up and the significant quantity that can be produced due to the high loadability possible with Kromasil stationary phases.

With the expanded Kromasil platforms to include small analytical particles, the analytical method generated in research and development can be seamlessly scaled-up to preparative chromatography. Labs and manufacturing facilities now benefit from using the same partner with the same stationary phase time and again independent of scale to bring drugs faster to market.