As clinical trials grow more complex, evidence of principal investigator oversight requires a more modern, risk-proportionate approach to demonstrate application of clinical and scientific judgment for areas of highest concern in patient safety and data integrity.
The new group will develop pharmacopoeial quality standards for 3D-printed medicinal products, reflecting the technology’s growing role in personalised medicine manufacturing.
EPR Issue 2 includes articles on manufacturing, drug formulation, microbiology, downstream bioprocessing, and more.
Data abundance alone does not equal intelligence within the digitized pharmaceutical laboratory. The next frontier demands connected systems, embedded AI governance and predictive capabilities that turn scientific data into actionable business insight.
Explore seven expert perspectives on the technologies and challenges shaping the future of pharmaceutical development and manufacturing.
As pharmaceutical laboratories face mounting pressure to accelerate timelines and manage growing data complexity, intelligent laboratory operations underpin the next generation of connected, autonomous lab environments.
Real-time monitoring has become standard practice in temperature-controlled distribution. The differentiator now is whether organisations can convert signals into decisions early enough to prevent excursions, reduce waste and strengthen resilience. As Vijay Paliwal, Vice President, Global Advanced Solutions & Customer Experience at Cold Chain Technologies explains, that shift is driving a new operating model for cold chain management: thermal assurance.
Exploring how mid-size pharma can meet European regulatory expectations without rebuilding infrastructure.
The biopharmaceutical industry has embraced Pharma 4.0 concepts, but the measurement infrastructure required to realise autonomous facilities and continuous bioprocessing remains underdeveloped. Process Raman spectroscopy offers continuous, non-destructive monitoring at frequencies aligned with cell culture dynamics, bridging the gap between control system capabilities and available data.