Making the journey to PAT and Pharma 4.0
Here, David Leitham, senior vice president and general manager at AspenTech, explains how implementing PAT pushes the industry towards Pharma 4.0.
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Here, David Leitham, senior vice president and general manager at AspenTech, explains how implementing PAT pushes the industry towards Pharma 4.0.
The collaborative work has produced the largest browsable resource linking rare protein-coding genetic variants to human health and disease that will accelerate targeted drug development.
The COVID-19 pandemic has exposed various issues with the software and data processes employed in the pharmaceutical industry and spurred rapid digital transformation at a rate never before seen in the sector. In this article, Jordan Stobaugh, Principal Research Scientist at AbbVie, discusses how software can improve data management and…
With companies acknowledging the value of their data, it becomes increasingly important that data integrity be assured – and data stewardship implemented. In this article, Ian Harrow and Thomas Liener, Consultant Project Managers at The Pistoia Alliance explain the importance of the FAIR (Findable, Accessible, Interoperable, Reusable) data principles, factors…
Pharma 4.0 represents the next step in the evolution of pharmaceutical manufacturing, and is heralded as providing manufacturers with better efficiencies, higher output and quality, as well as flexible production. Here, Dr Saly Romero-Torres highlights some of the key trends in digital transformation and explains why a strong informatics infrastructure…
Here, industry experts share their research, guidance and pharmaceutical knowledge.
Learn about how SampleManager LIMS software drives compliance and data integrity by providing clear traceability for all laboratory activities and data.
In this article, Aman Khera, the Global Head of Regulatory Strategy for Worldwide Clinical Trials, makes a case for regulatory involvement in drug development from start to finish and explains how the role of the regulator is changing, as well as what this means for pharma.
Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Ian Harrow and Thomas Liener, Consultant Project Managers at The Pistoia Alliance, explain the importance of the FAIR data principles; and Charles River Laboratories and Thermo Fisher Scientific showcase their unique data integrity services and discuss how they…
In this in-depth focus, find out about the key points to consider when implementing new software in the pharma development space and the current positions of the EMA and FDA with regards to nitrosamine contaminants.
An in silico trial evaluating a flow diverter in the treatment of brain aneurysms simulated the results of three human clinical trials.
Endotoxin automation using microfluidics enables simpler, compliant processes for pharma QC, QA, validation and IT. BET assay setup is simplified and less LAL is required.
In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…
Endotoxin automation doesn’t mean complex instrumentation and setup. See how microfluidics enables easy BET assay setup so QC labs achieve high throughput with less hands-on time.
From traditional LAL assays to cartridge-based systems, robotics and microfluidic BET automation, learn how different endotoxin testing systems work in this infographic.