17+ hour, 12+ min ago  (184+ words) Astra Zeneca's fixed-dose triple-combination inhaler Breztri Aerosphere has received US Food and Drug Administration (FDA) approval for the maintenance treatment of asthma in adults and adolescents aged 12 and older " marking the first time a single-inhaler triple therapy has been approved…...

18+ hour, 18+ min ago  (280+ words) Most bioreactor control decisions rest on data that is already out of date by the time it reaches the operator. It is the consequence of a process where critical parameters " viable cell density (VCD), glucose, lactate, key metabolites " are still monitored…...

17+ hour, 21+ min ago  (477+ words) European Pharmaceutical Review Process Raman spectroscopy: closing biomanufacturing's measurement infrastructure gap Biomanufacturing has committed to digital twins, autonomous operations and continuous processing, yet the measurement infrastructure these visions depend on has not kept pace. Inline process analytical technology, particularly process…...

4+ day, 18+ hour ago  (18+ words) The innovative approach for detecting nitrosamine impurities in APIs addresses limitations of traditional mass-based techniques, research says....

5+ day, 18+ hour ago  (14+ words) Small volume parenteral (SVP) manufacturing investment represents company's largest capital investment to date....

18+ hour, 57+ min ago  (438+ words) European Pharmaceutical Review Pharma 4. 0s missing middle This article illustrates how Raman spectroscopy can plug the measurement gap in biomanufacturing help to accelerate pharmas transition towards Pharma 4. 0. Biomanufacturing has spent the better part of a decade talking about autonomous facilities, digital…...

19+ hour, 20+ min ago  (11+ words) Otarmeni Regeneron's first genetic medicine to gain approval'European Pharmaceutical Review...

1+ day, 15+ hour ago  (150+ words) Dr Stacy Lindborg, CEO of IMUNON, reflects on the FDA's recent draft guidance that promotes the use of Bayesian modelling in clinical trials. In recent years, the US Food & Drug Administration (FDA) has been on a mission to modernise its…...

4+ day, 20+ hour ago  (358+ words) His two-decade tenure at the biopharmaceutical company has strengthened its aim for "convergent innovation" in medicine development. Credit: PJ Mc Donnell / Shutterstock. com Amgen's 21-year veteran, Dr David Reese, is retiring as its Executive Vice President and Chief Technology Officer…...

5+ day, 10+ hour ago  (218+ words) Abb Vie is building a new $1. 4 billion manufacturing campus in Durham, North Carolina, as its US centre of excellence for small volume parenteral (SVP) manufacturing. Over the next four years, Abb Vie plans to hire 734 employees, including engineers, scientists, manufacturing…...