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Quality & Compliance

Manufacture Quality & Compliance

Thinking Outside the Tox

| Sandy Mackay

Decisions around toxicology testing must be made using scientific methods, not emotions or politics.

Manufacture Small Molecules

Codes, Drugs, and Rock ‘n’ Roll

| Mark Davison

Europe has set the stage for safer supply chains with its Falsified Medicines Directive. Next, the spotlight could fall on using serialization to boost patient centricity.

Discovery & Development Business Practice

Relative viscosity screening of monoclonal antibody formulations at low concentration and viscosity

Viscosizer TD provides automated relative viscosity measurements with high reproducibility at low viscosity, to help identify molecules with abnormally high viscosity-concentration profiles at low sample concentrations as early as possible in the development pipeline

Discovery & Development Quality & Compliance

Language as Quality Control...

| Steven Schultz

... or sonicate until the cockroaches disappear. When writing is central to the job of assuring health, safety, and quality, can you afford to be loose with language prone to misunderstanding? Why take a chance? Here are a few strategies to edit your written work for quality control.

Manufacture Small Molecules

The Beginning of the End of Quality by Design

| Jasmine

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?

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.

Discovery & Development Formulation

Controlling Crystallization

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

Discovery & Development Formulation

As Clear as Crystallization

| James Strachan

Functionalized glass is shown to trigger nucleation of specific crystal forms

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.

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