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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The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
Combining near-infrared spectroscopy (NIR) hyperspectral imaging (HSI) and machine learning could offer a simpler, non-invasive alternative to established analytical techniques such as chromatography, research suggests.
An ultra-high sensitivity and super-resolution infrared imaging technique for single proteins could lead the way to a multitude of applications using infrared nanospectroscopy.
Raman mapping is a powerful tool that can be used to reveal details about the size and spatial arrangement of components throughout a tablet matrix. Here, Andrew Ewing, Don Clark and Fiona Clarke from the Materials Characterisation Team at Pfizer present a 3D imaging approach using Raman mapping to investigate…
This issue includes articles on Raman mapping of pharmaceutical tablets, delivery options for mRNA therapeutics, the use of high-throughput analytics for clonal cell selection and much more...
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.
Richard Crocombe of Crocombe Spectroscopic Consulting surveys the use of portable spectrometers in pharmaceutical manufacturing, with an emphasis on vibrational spectroscopy. Ideal and typical features of portable spectrometers are reviewed, alongside explanation of why device characteristics and sample presentation are critical to obtaining meaningful results.
Articles in this in-depth focus explore the applications of portable spectrometers and review their critical features, as well as comparing the results of standard and miniaturised NIR spectroscopy sensors in medicinal plant QC.
Download this whitepaper to discover the latest developments and research in QA/QC for biologic therapies via exclusive articles, interviews and application notes.
New research shows co-processed excipient is superior to non-co-processed when using near infrared (NIR) process analytical technology (PAT) to monitor direct compression tableting.
Here, EPR summarises a review of some of the benefits and disadvantages for spectroscopic techniques used to characterise the structure of therapeutic proteins in solid dosage forms.
Research suggests the development of new instruments and growing government investments, particularly in Germany, will drive growth of the European molecular spectroscopy market.
NIR spectroscopy is well-known for its sensitivity to water, which can be useful for detecting water variation in the sample matrix. However, for many other applications, water intake of the samples may be an issue and must be closely monitored to gauge the predictive performance of calibration models. This article…
29 July 2020 | By Charles River
In this webinar we discuss the results of our latest study where we evaluated the ruggedness, repeatability and specificity of commercially available rFC products, as well as our own recombinant product in development, against a large panel of endotoxins.
In this on-demand webcast, spectroscopy experts discuss recent advances in handheld Raman and NIR technology that lead to faster, more effective implementation and improved regulatory compliance.