Dispatches from AAPS
Extractables & leachables the biggest barrier to SU adoption, says WuXi
Extractables & leachables are the number one problem holding back the adoption and scale-up of single-use technology, according to a WuXi Apptech Director.
Archives for November 7, 2014
Dispatches from AAPS 2014
GSK ‘moves best people’ to keep Ebola vaccine manufacture in-house
GSK is keeping its Ebola vaccine production in-house, despite previously leaked documents which suggested the company could not ramp up volume of BS-2 manufacturing without impacting its other vaccine lines.
Amgen files FDA petition, lawsuit seeking info on Sandoz biosimilar manufacturing
The petition with the US FDA signals Amgen’s anger over Sandoz’s failure to disclose certain information from its biosimilar application, including how the biosimilar is manufactured.