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Validation of analytical procedures – ICH Q2(R2)
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
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Nuclear Magnetic Resonance (NMR) spectrometry
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Elevating pharmaceutical manufacturing processes with real-time insights
(Bio)pharmaceutical manufacturing is changing considerably, with key innovations enabling companies to rethink R&D, manufacturing, quality control and quality assurance (QC/QA) operations. The spotlight is squarely on process analytical technology (PAT), which underpins the successful transition towards highly effective advanced manufacturing strategies. Martin Gadsby, Chairman of Optimal Industrial Technologies, looks at how this transformative approach…
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European Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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Portable NIR sensors in medicinal plant quality control
In the quest for fast and reliable ingredient analysis, Christian W Huck, Krzysztof B Bec and Justyna Grabska from the Institute of Analytical Chemistry and Radiochemistry at the University of Innsbruck, consider the use of portable NIR spectroscopy, comparing the results from standard and miniaturised sensors.
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NMR spectroscopy to enhance biologic drug delivery and stability
Review shows nuclear magnetic resonance (NMR) spectroscopy has the potential to enhance biologic drug formulation, optimising delivery and bioavailability.
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VIRTUAL ROUNDTABLE HIGHLIGHTS: Emerging tools for the analysis of biologics and biosimilars
In this virtual roundtable, Scott Bradley (Principal Research Scientist, Eli Lilly and Company), Joan Malmstrøm (Principal Scientist, Novo Nordisk) and Kelly Sackett (Principal Scientist, Pfizer) exemplified how high-resolution nuclear magnetic resonance (NMR) is a key technology that provides critical information about protein structure and dynamics. Here, the participants offer some…
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Solid- and Liquid-State NMR for monitoring of polysaccharide antigen in the manufacturing process
Francesco Berti, Scientific Director at GSK Vaccines - Siena, Italy, reveals how NMR spectroscopy tools are invaluable in vaccine production.
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European Pharmaceutical Review Issue 3 2021
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,…
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European molecular spectroscopy market to value $2.83bn by 2027
Research suggests the development of new instruments and growing government investments, particularly in Germany, will drive growth of the European molecular spectroscopy market.
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How can NMR spectroscopy help protein biopharmaceutical development?
Nuclear magnetic resonance (NMR) spectroscopy is a technique that most have heard of but many avoid, especially when dealing with larger biological macromolecules. Why? The common wisdom is that NMR can be complicated, expensive and involves quantum physics and complex equations. In the fast-paced industrial biopharmaceutical environment there may be…
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Continuing electron paramagnetic resonance (EPR) innovation with rapid scan EPR
Analogous to nuclear magnetic resonance spectroscopy, EPR measures electron spins, rather than those of atomic nuclei. Its investigative power has always offered unique insight, but it seems that only now is the technique coming into its own.
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Revealed structure of glucagon fibrils could improve drug formulation
Researchers have discovered the formulation of glucagon fibrils, which could inform drug formulation for diabetic patients.
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Biopharma Processing & Development In-Depth Focus 2019
Today’s biopharmaceutical developers need accurate and precise information at all stages of research and development in order to bring safe and effective therapies to patients. This in-depth focus features novel perspectives from industry experts that serve to illustrate which technologies and systems are benefitting this cause.
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Ebselen provides promising new avenue for treatment of MND
An international study has shown that the drug-molecule ebselen can correct many of the toxic characteristics of a protein that causes some cases of hereditary motor neurone disease...
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National Physical Laboratory re-launched to improve access to health innovations
NPL's new approach informed by government priorities, consultancy with industry and the NHS, and a century of expertise, will see it focus on some of the world’s biggest health challenges, from supporting the diagnosis and treatment of cancer and dementia, to reducing attrition rates in drug development, to creating new…
