Isolation of aseptic processes is not a new technology. Rigid stainless-steel isolators have been available...
Reducing time to market is one of the ultimate goals for every pharmaceutical lab.
Being the first on the market brings a competitive advantage for prescription, over-the-counter (OTC), or generic drug manufacturers. Applying quality-by-design (QbD) principles at the formulation phase can prevent tablet defects at an early stage and thereby drastically reduce time during the complex and troublesome phase of scale-up.
Waiting until late in development in the production-size phase may force scientists to solve formulation issues at the pilot level or even worse in actual production. A QbD approach secures the scale-up to production with maximum safety right from the beginning.