Archives for July 23, 2013

← 2013

Biopharma Companies Look to New Chromatography Columns

By Zachary Brennan

Biopharma firms, particularly those producing insulin and five of its analogues, have another option in the market of sub-2 micron solid-core chromatography columns with a recent offering from Waters.

Aussie Team Uses Hot Ethanol to Make Smaller API Particles

By Gareth Macdonald

Appreciating warm alcohol, like being rubbish at cricket, is no longer a solely British preserve with researchers in Australia developing a hot ethanol-based manufacturing method that, they claim, produces smaller, more uniform API particles.

To QbD or not to QbD? That is the Question...

By Dan Stanton

Europe may soon approve the first biologic made according to quality by design (QbD) principles, but opinions are still split over whether the approach should even be applied to biopharmaceuticals.