Optimizing Chromatographic Purification for Rapid Results in Chemical Manufacturing White Paper

The Biotage approach to large-scale purification in the manufacturing environment is based around a practical, scalable approach to flash chromatography. 

Methods are developed in the laboratory using dedicated equipment, and the methods are scaled up using a simple scale up procedure based on utilizing the same media and simply scaling up the column size, flow rate and loading appropriately, to generate identical results.

Introduction

It is imperative that pharmaceutical processes have the flexibility and robustness to quickly output targets of interest – from small molecules and APIs for drug products to complex structures or chemical sensors that may be used in kits or other diagnostic devices. In chemical manufacturing, for example
in the pharmaceutical industry, target molecules are synthesized on a large scale in dedicated manufacturing plants. Such processes represent the culmination of a great deal of research and development, where much time and consideration has been spent scaling laboratory based synthetic routes into commercially and practically viable manufacturing procedures.

The synthetic route taken to reach a target molecule is only half of the story. At the end of each chemical transformation, there is still the same requirement for purification and clean up procedures in order to ensure purity criteria for delivery to the next stage are met. 

Molecules of interest may be isolated from complex reaction mixtures containing starting materials, catalysts, solvents, products and by-products. Isolating desired molecules while eliminating the undesired is in many ways one of the most challenging aspects of synthetic chemistry.