news
Recombinant bacterial endotoxin testing techniques shown to be inferior
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
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Microbiology
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Is the compendia-recommended microorganism test panel truly representative?
A recently published paper suggests the test panel of microorganisms needs to be reviewed and likely expanded to ensure it is suitable for application in the pharma industry.
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Discussing developments in RMM with Dr Tim Sandle, Bio Products Laboratory
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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Quality driven solutions from discovery to commercialisation
We offer high quality analytical testing solutions for pharmaceutical and biopharmaceutical products through all phases of drug development, from discovery through early development and commercialisation. Find out more in this guide…
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Pharmaceutical sterility testing market to value over $1000 million by 2027
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.
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USP to release <922> Water Activity method for pharma
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.
video
On-demand webinar: Optimising MALDI-TOF for filamentous fungi ID
Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
webinar
Quality Risk Management tools to improve data integrity in micro QC
12 April 2021 | By Charles River Laboratories
Watch this on-demand webinar with Jordi Iglesias to learn how you can improve the data integrity of your microbiological QC assays.
whitepaper
Whitepaper: EU GMP Annex – sterile manufacturing
This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
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On-demand webinar: Testing disinfectant agents for antimicrobial action on hard surfaces
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.
news
Novel blood cleansing device to enter first-in-human trial
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.
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What is on the horizon for the pharmaceutical packaging equipment market?
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.
news
Fujifilm to launch rapid antigen COVID-19 test in Europe
Having received the CE certificate, Fujifilm can now launch its highly-sensitive, rapid antigen test kit for SARS-CoV-2 in Europe.
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FDA grants Emergency Use Authorisation to Abott’s SARS-CoV-2, influenza and RSV test
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).
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On-demand webinar: Key elements of a sterility assurance program
This on-demand webinar will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle.
