Quality & Compliance

Manufacturing specialists must develop cell therapy factories that can meet high demands.

Predicting and measuring protein aggregation is a critical challenge in the formulation of biopharmaceuticals. This article describes an analytical tool that hits the ‘sweet spot’ of protein aggregation measurement

Nominations for the 2017 Power List are now open and will close on February 1, 2017.

The latest edition of the European Pharmacopoeia was published in July 2016 and some large changes are afoot.

Many people struggle with QbD, but there are secrets to success…

Sitting Down With… Susanne Keitel, Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe in Strasbourg, France.

Isn’t it time to move with the times and relegate manual and outdated processes?

We should look to Warning Letters – and the subsequent solutions – to benefit from the blunders of others.

Packaging components can leach into drug products and become foreign impurities. Guidelines exist for the testing of drug products for elemental impurities, but how are these applied to elemental impurities derived from drug product packaging?

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