There are many challenges upstream and downstream in manufacturing a biotech drug.

The crystalline structure of pharmaceutical solids can sometimes be altered during processing. X-ray powder diffraction and near infrared spectroscopy can be used to determine the amorphous and crystalline content of a model substance. The two techniques' precision, accuracy, detection limit and the speed of analysis are compared.

With appropriate standardization from an interfacing point of view, separation science will find a broader audience in PAT.