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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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Microbial Detection
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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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Innovation in real-time next-generation sequencing provides pharmaceutical benefits
Tim Sandle explains how next-generation sequencing (NGS) could aid in the development of novel antimicrobials to overcome multi-drug resistance.
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Rapid microbiology testing market set to be worth over $6 billion in 2026
Rising at a CAGR of 8.2 percent, the rapid microbiology testing market is predicted to grow over the next five years.
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Glove prints are the most effective microbiological monitoring method during aseptic handling, finds study
Researchers evaluate the various microbiological monitoring (MM) methods employed inside a laminar airflow or safety cabinet in hospital pharmacies.
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Novel COVID-19 test could significantly reduce testing time
The new COVID-19 test, called RTF-EXPAR, was able to accurately detect the presence of SARS-CoV-2 viral RNA in under five minutes.
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QA/QC & Analytical Techniques In-Depth Focus 2020
In this in-depth focus find out why deep ultra-violet (DUV) handheld devices could replace current onsite cleaning verification applications and how Raman spectroscopy could be used to improve COVID-19 detection.
![Scientist using scanner to read barcode - MODA-EM™ Paperless Solution [© Lonza, Basel]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Lonza-MODA-Solution-300x278.jpg)
![Scientist using scanner to read barcode - MODA-EM™ Paperless Solution [© Lonza, Basel]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Lonza-MODA-Solution-e1607446278766.jpg)
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Lonza’s MODA-EM™ Paperless Solution to be implemented at the UK’s New Vaccines Manufacturing and Innovation Centre
The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) has selected Lonza’s MODA-EM™ Solution to digitise its Microbiology Quality Control operations. The MODA EM™ Platform will form a vital part of ongoing work that will support the VMIC coming online a year ahead of schedule.
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Primary validation of the growth direct bioburden system and media
This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.
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QA/QC & Analytical Techniques In-Depth Focus 2020
Read articles on validating rapid microbial methods according to regulatory requirements and how solid-state NMR spectroscopy can be used to analyse pharmaceuticals in this in-depth focus.
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Return to work for life sciences: an evolving challenge
Helen Farr, a Partner at Taylor Wessing, discusses the hurdles that life science businesses must tackle to bring employees back to work safely; whether that be working remotely or returning to the lab.
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Release of sterile medicinal products – looking at the focal points
There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.
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Expert view: Our air samplers are designed to perfectly match customer needs
A discussion between experts Roger Haas, Head of Environmental Monitoring Franchise at Merck KGaA, Darmstadt, Germany, and Ronny Zingre, CEO of MBV AG.
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Application Notes & Whitepapers 2020
The latest applications and advice from industry experts.
