The stability of macromolecule-based drugs and vaccines is a key issue in the development of biopharmaceuticals. In addition to the intrinsic instability of the molecules themselves, ...

An ambitious survey of characterization techniques presents current information. Like beauty, preformulation is in the eye of the beholder. As coeditor Harry Brittain points out in his introduction to ...

The use of biotherapeutics, such as antibodies and other protein molecules, to treat diseases is a rapidly growing field in the pharmaceutical industry. Biotherapeutics are often required at high ...

Preformulation represents an early-stage opportunity to facilitate the eventual movement of a drug substance into a commercial product. Strategies to optimize the preformulation process were outlined ...

In biotherapeutic development, hitting roadblocks due to insufficient developability assessment is a common and costly setback. Traditional particle analysis methods demand more sample volume than is ...