Dispatches from the Biological Production Forum
Valeant puts head in the Cloud to manage over 800 CMOs
Managing over 800 CMOs could lead to quality and compliance nightmares but Valeant says it has come up with a unique cloud-based strategy.
Archives for May 12, 2014
Dispatches from the Biological Production Forum, Dublin
Sartorius: QbD for single-use systems could help assure quality
Though industry has fully embraced single-use, manufacturers of such systems need to remove the risk of extractables and leachables and control the supply process according to Sartorius.
US FDA unveils long-awaited biosimilar guidance
The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.
Novartis talks stem-cells but no word on Gamida rumours
Novartis says stem cell-based therapies will form an important part of its pipeline after reports in the Israeli media the firm pulled out of a deal to buy Gamida Cell.