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Make confident operational decisions by understanding your microflora
Are you leveraging all the information from your QC data? A secure, compliant and powerful data management tool is critical for maintaining a state of control.
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Microbial Detection
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Methods for strain comparison and differentiation of environmental isolates
Identification of environmental isolates is a regular requirement in pharmaceutical manufacturing, and strain differentiation can be valuable in a variety of circumstances. There have been huge advances in the technology available for sequencing bacterial genomes, which has fed through to the analyses that are available to pharmaceutical microbiologists. NCIMB’s Identification…
news
Microbial identification market valued at $10.7 billion by 2032
Technological innovations like automation and real-time analysis, as well as industry collaboration are anticipated to become key tools in the global microbial identification systems market going forward.
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Large bacterial culture volumes can be filtered without centrifuge
The study observed that using a modified vacuum filtration system assisted in the filtration of large volumes of bacterial cultures, removing the need for centrifuges.
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Validating FTIR for rapid cleaning verification
Researchers simulated the effect of surface roughness on Fourier-transform infrared (FTIR) spectroscopy, developing guidance for validating the technique for rapid cleaning verification.
podcasts
EPR Podcast Episode 15 – Modernising microbiology – Sophie Bailes and Miriam Guest, AstraZeneca
How is the implementation of artificial intelligence, machine learning and virtual reality shaping the microbiology lab of the future? What do these innovations mean for personnel? Find out in this episode with AstraZeneca...
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Product hub: How can CGT manufacturers ensure product safety with Microbial Solutions QC test methods?
Innovation forms the basis of every emerging technology. That is certainly the case with cell and gene therapies (CGTs), and the search for efficient quality control (QC) test methods continues to grow in this pharmaceutical sector. One of the most important factors to consider while deciding on a QC method…
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Progress in the implementation of biofluorescent particle counters
Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…
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Environmental Monitoring In-Depth Focus 2022
Features in this in-depth focus explore the development of a sustainable approach to bacterial endotoxin testing (BET) within a global enterprise, as well as progress towards the use of biofluorescent particle counters for water bioburden applications.
news
LAMP assays to enable rapid and sensitive detection of BCC
Here, EPR presents a novel loop-mediated isothermal amplification (LAMP) assay developed to enable the rapid and sensitive detection of Burkholderia cepacia complex (BCC) in pharmaceutical manufacturing.
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NA to NAM ratio as a biomarker for cell therapy sterility
Study shows nicotinic acid (NA) to nicotinamide (NAM) ratio enables detection of early-stage microbial contaminations in cell therapy products.
whitepaper
Product hub: Environmental monitoring: a critical and challenging requirement
Read about bioMérieux's new system, 3P® ENTERPRISE - an end-to-end solution that fully digitalises and automates the EM process.
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Efficient shutdown recovery: leveraging RMM to unlock value and ensure environmental quality
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
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Testing non-inferiority for accuracy of quantitative microbiological methods
Authors Edwin van den Heuvel, Maliheh Heidari, Kathrin Möllenhoff and Pieta IJzerman-Boon compare statistical analysis methods for determining comparable accuracy of alternate and compendial microbiological methods.
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The importance of sterility testing in biopharmaceutical manufacturing
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
