Quality & Compliance

Where did Quality by Design come from? Where will it lead to in pharma? And is there a day when the concept will no longer exist?

The term ‘packaging’ may not immediately evoke excitement – but without innovation in the field, some therapies wouldn’t even reach market. In other words, don’t judge a box by its cover because there’s more to packaging than meets the eye… and even more lies on the horizon.

Researchers working to gain greater knowledge into crystallization believe that functionalized glass can trigger nucleation of specific crystals.

Functionalized glass is shown to trigger nucleation of specific crystal forms

This application note explores the use of the Morphologi G3-ID for Morphologically-Directed Raman spectroscopy (MDRS) to identify and analyze contaminants including protein aggregates present in a stressed sample of lysozyme, and to compare particles held in suspension within a thin path wet cell with those collected on a filter membrane.

This application note provides an example of how Archimedes can be used to detect and quantify the formation of protein sub-visible particles and the introduction of silicone oil droplets, in response to shear stress.

Work performed in conjunction with Spiber Technologies, Uppsala, Sweden. Use of dynamic and electrophoretic light scattering to assess the effects of protein formulation composition

Pharma suppliers are teaming up to take ready-to-use technology to the next level.

Medicine packaging leaders forming the “Matrix Alliance” will bring improved container and closure systems to market.

Two antibody samples were characterized using column calibration and multi-detection SEC, and the results compared...