Development

Getting time on your side

Speeding up peak performance

An important task in the development stage is to isolate substances for clinical trials, toxicological studies, and so on. The quantities required can be from a few milligrams up to several kilograms. The faster the isolation, the sooner the subsequent studies and trials can be performed, and the sooner the product can be on the market. The speed at which the results are obtained and verified will affect the time taken to get the drug through the clinical trials.

In other words, time is not only crucial for the development stage: it is a competitive factor for the whole process of developing a new drug.

Analytical performance at any scale

A fast and efficient process resulting in sufficient amounts of high purity substance is looked for which necessitates problem-free chromatography with no undesired results. In cases where Dynamic Axial Compression (DAC) columns are used, rapid, efficient and sometimes frequent packing and unpacking is necessary.

Reproducibility is vital, both when changing to a new column or batch, and when a DAC column is repacked. It is important that the isolation of pure substance or method development are not compromised. Every time a column is changed or repacked, the risk of compromised results is increased.

This means that the silica used needs to be extremely robust, with high chemical and mechanical stability, providing a long life-time with unchanged properties at this stage. The silica must also be able to withstand separation under tough conditions, e.g. mobile phases with very low or high pH, or when an aggressive buffer or additive is used. In addition, producing large amounts of substance in a short time requires a silica with a high loading capacity, allowing large amounts to be processed in every injection.

The challenge of choosing the right one

Today, hundreds of silica brands are available for analytical HPLC. For larger-scale HPLC the choice is, however, limited. In fact, there are only a handful of silicas that can be used when going from analytical scale to development and production scale.

We have seen that using a high quality silica saves you time in development. And if chromatography is also to be used in final production, a key factor is that the silica is also available in multi-kilogram or ton quantities.

Scalability, with identical performance from analytical through development and up to large process scale is essential, in order to avoid unpleasant surprises when planning production.