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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.
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…
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…
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.
Articles in this in-depth focus discuss how you can compare the accuracy of alternate and compendial micro methods and explore the use of RMM to enhance microbial control alongside compendial methods.
The Celsis Adapt™ unlocks advantages of utilising a single in-house RMM, achieving critical results necessary to ensure patient safety.
Rapid microbiological methods are being enhanced by artificial intelligence (machine learning in particular). The aim is to speed up analysis; increase accuracy; avoid error and introduce a level of automation. Examples include microscopy, colony counting, and microbial characterisation and matching – each of which is based on improvements in image…
In this in-depth focus, discover how Raman spectroscopy is used by Bristol-Myers Squibb to identify counterfeit pharmaceuticals and the role of artificial intelligence in rapid microbiological method development.
This journal features articles discussing what knowledge could help the industry to prevent the next nitrosamine-like contamination event, the key steps when validating analytical techniques for cell and gene therapies and how artificial intelligence is shaping microbiology. Also in this issue, using Raman spectroscopy and hyperspectral imaging to detect counterfeit…
Download this whitepaper to discover the latest developments and research in QA/QC for biologic therapies via exclusive articles, interviews and application notes.
Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.
A new paper shows thermal imaging (infrared thermography) can detect E. coli and S. aureus bacteria after just six hours of incubation, long before it is visible to the human eye.
Microbial detection methods are inherently flawed by three key factors, here we summarise Tim Sandle’s explanation of the concerns surrounding microbial methods and sampling.
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
In this video, Dr Tim Sandle explains how COVID-19 has impacted the application of rapid microbial methods (RMM) and much more...
