Quality by Design (QbD) Approach for Individualized Products Based on Additive Manufacturing

Manufacturing of pharmaceuticalsPharmaceuticals has not traditionally been in the forefront of implementing recent development within engineering sciences. The most visible part of pharmaceutical sciences is often the search of new active substances and commercial driver is the identification of a “blockbuster” molecule. At the same time, the classical production of pharmaceuticals has been driven by Quality by Testing thinking and engineering solutions dating back even to patented inventions from 1840s (tabletTablet). Pharmaceutical quality systems have been heavily based on testing the quality into the end-product and intensive documentation of all the steps of the production cycle. However, the increasing pressure on cost of medication for society and an obvious need for more individualized products challenge all this. The way of thinking about quality has not been fostering innovative manufacturing solutions paving the way toward more efficient production systems and tailor-made therapies. All this has been changing rapidly during the past decade and the innovative pharmaceutical manufacturing sciences have matured into an integrated part of broader pharmaceutical sciences.