Standards & Regulation

Angus Dalgleish tells us about his experience with EU regulation – and why he thinks Britain should leave the EU.

As politicians and the public argue over the minor point of the UK leaving Europe, we ask a more important question: what will a “Brexit” mean for the global pharmaceutical industry?

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.

A US coalition seeks lower prices for US prescription drugs, but could their proposals undermine the competitive market?

Innovation is increasingly coming from small biotechs, but such companies rely on external funding to develop the compounds. A solid regulatory strategy is essential to convince investors to fund the further development.

Sitting Down With... Christian Schneider, Director of the National Institute for Biological Standards and Control (NIBSC), UK.

The use and misuse of antibiotics is a major driver behind the drug-resistance problem, but large environmental discharges of antibiotics from pharma manufacturing can also contribute. It’s time for companies to live up to their ethical responsibilities.

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.