Standards & Regulation

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.

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

Despite controversies, Robert Califf will finally take the reins at the FDA.

Does incentivizing informants deter off-label drug marketing ? Should other countries follow suit?

The stability of drug formulations is essential. But what should be monitored – and how often?

Neonates have been underserved, potentially missing out on life-giving scientific advances.

Regulators come down hard on facilities that come up short.

The UK Competition and Markets Authority (CMA) has handed out a £37.6 million fine to GSK for paying out “value transfers totaling over 50 million pounds” to competitors between 2001 and 2004 to delay the introduction of generic versions of its branded anti-depressant drug, Seroxat (paroxetine).

The Morphologi G3-ID can be used to generate component-specific particle size and shape data required to aid the reverse engineering of solid oral dose formulations. Here, we provide an example case study for a powder formulation.