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Standards & Regulation

Discovery & Development Business Practice

Trials and Tribulations

| Angus Dalgleish

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

Business & Regulation Business Practice

The Great British Debate

| James Strachan

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?

Manufacture Packaging

Packaging the Future

| Mike Schäfers

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.

Business & Regulation Business Practice

CSRxP Vs PhRMA

| James Strachan

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

Business & Regulation Business Practice

Making Small Biotech Work

| Bruno Speder

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.

Business & Regulation Clinical Trials

Back to Biologics

| Christian Schneider

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

Business & Regulation Standards & Regulation

Time to Limit Antibiotic Pollution

| Johan Bengtsson-Palme, D. G. Joakim Larsson

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.

Discovery & Development Business Practice

Morphologically-Directed Raman Spectroscopy used for the characterization of protein aggregates in suspension

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.

Discovery & Development Formulation

Therapeutic protein products used for the differentiation and characterization of subvisible particulates

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.

Manufacture Drug Delivery

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| Sponsored by Schott

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