As Biocorp prepares for the market launch of its connected injector pen add-on, Mallya, Eric Dessertenne and Arnaud Guillet share insights about key steps in the company’s development. The article discusses the many partnership Biocorp has entered in to, and includes a mini-interview with Sergio Monti, Plant Manager for one such partner, V.A.R.I.
David Belton discusses the meaning of quality by design in novel respiratory drug delivery device development. He covers how, with more novel devices, prior knowledge may be insufficient for a standard FMEA-style risk analysis, and alternate science-based methods, such as functional mapping and knowledge scoring, can help in achieving QbD.
Tom Lawrie-Fussey and Lucy Sheldon introduce “Wizard of Oz” testing, named after the classic novel and film, whereby experimenters can field test concepts at a very early stage by giving the illusion of a finished product, saving potential costly and time-consuming changes further along the development process.