In this article, Liz Thorn, Senior Consultant, Diagnostics at Team Consulting, explores the various in vitro diagnostics (IVDs) techniques available and where they are best applied in the context of influenza and COVID-19.
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An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
A recently published paper suggests the test panel of micro-organisms needs to be reviewed and likely expanded to ensure it is suitable for application in the pharma industry.
In this video, Dr Tim Sandle explains how COVID-19 has impacted the application of rapid microbial methods (RMM) and much more...
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Reports suggest the global sterility testing market will grow because of the expansion of pharma and biopharma, increasing R&D activities and the launch of new products.
The new chapter, to be released in May, highlights the benefits of water activity measurement, as well as potential applications and best practices for use in pharmaceutical manufacturing.
Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
12 April 2021 | By Charles River Laboratories
Join Jordi Iglesias on 1 June at 15:00 BST, as he summarises the ICH Q9 Quality risk management GMP document and explains how you can use the approach and tools described to proactively improve your microbiological QC assays in terms of data integrity.
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
The Garnet™ therapeutic product, which can capture more than 100 clinically relevant bacteria, fungi, parasites, toxins and viruses from the blood, will soon begin clinical testing.
European Pharmaceutical Review’s Hannah Balfour outlines the findings of market research reports exploring the challenges and drivers for the pharmaceutical packaging equipment market between 2020 and 2025.
Having received the CE certificate, Fujifilm can now launch its highly-sensitive, rapid antigen test kit for SARS-CoV-2 in Europe.
The PCR based Alinity™ m Resp-4-Plex molecular assay can detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV).