A new diagnostic method for detecting a rare kidney stone disease has recently been developed at the University of Iceland. Instead of using urine microscopy, which has certain disadvantages, the diagnostic method is based on mass spectrometry of plasma samples. Preliminary clinical data shows very promising results both in terms of detecting the disease and therapeutic drug monitoring. Design of Experiments (DOE) was used as a chemometric approach to optimize the assay. Below is a summary of the assay development and optimization.
Using multivariate models in a regulated environment for continuous manufacturing of pharmaceuticals
Continuous manufacturing is one of the key trends within the pharmaceutical industry, both for the production of ‘classical’ drugs as well as large molecules. Companies are looking for ways to shift from traditional batch processing to a continuous method of operation. The main advantages associated with these processes are more room for modularity, automation and flexibility due to a smaller footprint, as well as more consistent quality of the drug product.
