BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.
The authors conclude that miniature bioreactors can adequately predict the cell culture kinetics in scaled-up reactors using equal mixing times.
This article defines the concept, justification, and method of removal of out-of-trend points in stability modelling and shelf-life prediction.
Heightened global uncertainty could slow bio/pharma development activity.
Industry experts discuss what the outsourcing market holds for 2016.
AMRI adds analytical capabilities to its outsourcing services offerings with the acquisition of Whitehouse Labs.
CMO industry consolidation may be frustrated by a dearth of attractive assets.
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.
Can the feds negotiate Medicare Part D prices?