All Assays articles
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News
Internationally-compliant framework backs rabbit pyrogen test alternative
The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.
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ArticleMicrobiology/RMM In-Depth Focus 2025
This in-depth focus features articles on rapid microbiological methods, quality control, and using AI to read agar plates.
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ArticleUnderstanding endotoxin cartridge testing: frequently asked questions
Charles River’s Courtney Wachtel and Sherri Hopple discuss endotoxin cartridge testing, its application and how it differs from traditional BET assays.
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NewsUnique testing regimen could prevent nuclease contamination
Biannual routine testing in the laboratory reduces both the likelihood of nuclease contamination occurrence and its impact, a study suggests.
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Whitepaper
Application note: Equivalency of PCR-based rapid sterility testing and the compendial culture method
Sterility testing is a critical component of release testing for any cell therapy product since microbial contamination of cell therapy products can potentially kill recipients.
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NewsNew method could replace microbiology CFU assay
A new, more efficient colony counting method called the Geometric Viability Assay (GVA) could enable microbiologists to test potential new drugs such as antibiotics more quickly.
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WhitepaperUnder the microscope: QC compliance and environmental isolates
In this Q&A Microbiologics’ Brianna DeWitt explores how to make QC with environmental isolates simple and reliable while conquering compliance with regulations and standards.
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Whitepaper
Application note: Low Endotoxin Recovery case study
This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference
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NewsEMA publishes updated Q&A for ICH M10
An updated Q&A document for ICH M10 'Bioanalytical Method Validation and Study Sample Analysis’ has been published by the European Medicines Agency (EMA).