4+ day, 1+ hour ago  (18+ words) The innovative approach for detecting nitrosamine impurities in APIs addresses limitations of traditional mass-based techniques, research says....

5+ day, 1+ hour ago  (14+ words) Small volume parenteral (SVP) manufacturing investment represents company's largest capital investment to date....

1+ hour, 52+ 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…...

2+ hour, 15+ min ago  (11+ words) Otarmeni Regeneron's first genetic medicine to gain approval'European Pharmaceutical Review...

22+ hour, 44+ min ago  (150+ words) Dr Stacy Lindborg, CEO of IMUNON, reflects on the FDA's recent draft guidance that promotes the use of Bayesian modelling in clinical trials.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…...

5+ day, 2+ hour ago  (334+ words) CMAC, an academic research centre for pharmaceutical manufacturing and digital CMC in the UK, led by the University of Strathclyde, has connected data across multiple, siloed systems for the first time. It accelerates the development of new medicines and processes…...

1+ week, 6+ day ago  (447+ words) Laboratories across research, clinical, and applied testing environments are increasingly turning to automation to improve efficiency, consistency, and scalability. As PCR and q PCR assays grow in both volume and complexity, laboratories face increasing pressure to scale throughput while maintaining…...

2+ week, 20+ min ago  (133+ words) Download this application note to learn how integrated digital systems can improve data integrity and support higher levels of quality management maturity in regulated manufacturing environments. In the context of Industry 4. 0, quality is no longer a downstream control activity but…...

2+ week, 18+ min ago  (147+ words) The MAS-100 Libra" is an automated passive air sampling system for cleanrooms, combining reliable microbiological monitoring with preserved laminar air flow, while supporting continuous air monitoring in line with the Annex 1 (Eudra Lex 2022) requirement for critical areas. Figure 1: A side…...

2+ week, 2+ hour ago  (258+ words) Credit: lev radin / Shutterstock. com Telix has the option to co-fund commercialisation and profit-share or earn up to $2. 1 billion in milestone payments plus royalties. Additionally, Regeneron will have the option to include four more programmes with additional upfront payments. "Regeneron…...