The science of smarter sampling for drug development

Competency-based medical education (CBME) requires a vigorous and multidimensional assessment system. In order to successfully implement CBME, assessment processes must be continuous and frequent.

Following the patent of the innovative “Espresso” intravenous delivery device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a filling line to meet the unique requirements of the solution. Particle Measuring Systems’ advisory team leveraged their industry and regulatory expertise to oversee the development of the aseptic filling process and the environmental monitoring system by applying proven risk management techniques. Using this case study, we provide practical insights for Quality by Design principles with input from IBI and Comecer.

Vibrational Circular Dichroism (VCD) is used to determine the absolute configuration of compounds in solution. As a result, it doesn’t require crystalline substances.

Spray drying is one of the most remarkable technologies currently to be applied to pharmaceuticals. It is a continuous process that converts, in a single step, a liquid feed into a powder and is an ideal process when precise attributes such as particle size, morphology and stability are required.