QA/QC

iStock/SteveAllenPhoto

More fake Xeplion withdrawn in Denmark

By Gareth Macdonald

A fourth batch of Janssen-Cilag’s schizophrenia drug Xeplion has been withdrawn in Denmark after the identification of counterfeit packs.

iStock/sal73it

Unorderly Brexit will cause UK drug shortages warn industry groups

By Gareth Macdonald

UK patients face drug shortages unless Tory Government Ministers negotiate an orderly withdrawal from the EU – Brexit – that safeguards existing approvals and continued regulatory cooperation according to pharmaceutical industry groups.

Lonza facility in Walkersville, Maryland (source Google maps)

update

US FDA warns Lonza about Walkersville site

By Gareth Macdonald

The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.

Image: iStock/cacaroot

1st Stem Cell Community day in Germany

For stem cells 'the process is the product,' says Pluristem

By Dan Stanton

Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.