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NMR relaxometry is a promising technique for identifying pharmaceutical raw materials without the need for laboratory testing. Gregory Webster, Senior Principal Research Scientist at AbbVie, considers the use of NMR relaxometry for identity confirmation of monoclonal antibodies.
A key element of development for new molecular format biological products is to leverage the appropriate analytical tools to enhance product and process understanding throughout the development lifecycle. Here, Ian Anderson, Mostafa Zarei and Qifeng Zhang at Lonza highlight the benefits of using mass spectrometry technologies to accelerate and de-risk product…
Cell-based therapies have the potential to regenerate heart tissue as an alternative to heart transplants. Here, Dr Ibon Garitaonandia, Chief Scientific Officer at CellProthera, shares how CD34+ cells are demonstrating promising results in clinical studies.
Transferring analytical methods between companies is often a challenging, time-consuming manual process. In this Q&A, Dr Birthe Nielsen, Project Lead at The Pistoia Alliance, speaks about an ongoing project to digitally transfer HPLC data between different vendors.
Manufacturers of innovative therapies and other stakeholders handling blood, tissues and cells must prepare for stronger European rules. Ulf Grundmann, Elisabeth Kohoutek and Lara Sophie Hucklenbroich of King & Spalding elaborate on what this means for manufacturers of advanced therapy medicinal products.
Jessicca Rege of Alkermes provides insights into how protein engineering approaches have led to the development of novel therapies that harness the immune system’s capabilities to fight cancer.
Here, Dave Elder explores proposals for new FDA rules on tobacco product manufacturing. How could strategies for controlling tobacco-specific nitrosamines compare with those for nitrosamine drug substance-related impurities?
Discover how the Alliance iS HPLC System from Waters is set to become the modern QC laboratory’s strongest ally.
A data-driven approach to optimise sanitisation and improve process control of the microbial parameter in a water system.
Solving the sector-specific challenges of life sciences while enabling innovation requires data integrity, with data collected and analysed at the source in real time, explains Greg Hookings, Industry Director, Stratus Technologies.
In this article, Neil Almstead, Chief Technical Operations Officer at PTC Therapeutics, shares his view on why collaboration is key to streamlining manufacture of gene therapies.
In this article, Dr Rajiv Vaidya, Head of Manufacturing Science & Technology at Andelyn Biosciences, explores strategies for improving the scalability and cost‑effectiveness of AAV production while maintaining regulatory compliance.
In this edition, experts from Institute of Biomedical Research Antoine Marxer and Associates of Cape Cod International share insight on endotoxin testing.
In this In-Depth Focus are articles on the potential of AAV gene therapies and what gene therapy manufacturers can gain from collaboration.
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
