27 02 2025

Testing for pyrogenic contamination in sterile parenteral drugs and medical devices is a crucial quality control measure mandated by international regulatory bodies. The European Pharmacopeia (EP), European GMP – Annex 1, USP 151, and FDA Guidance all stress the importance of rigorous pyrogen ...

13 02 2025

Unprecedented Accuracy and Sensitivity for Enhanced Food Safety CellMade®, a leading provider of food safety solutions, is proud to announce its groundbreaking advancements in food allergen testing. By harnessing the power of multiple state-of-the-art techniques, including PCR, ELISA, Mass Spectrometry, ...

27 02 2025

Elevated Precision and Reliability for Superior Grain and Food Safety CellMade®, an innovative provider of mycotoxin detection solutions, is excited to announce its latest advancements and product launch, designed to revolutionize mycotoxin testing. Leveraging a suite of advanced methodologies ...

05 03 2025

Food allergies are a growing public health concern, impacting millions worldwide. For food manufacturers and processors, ensuring accurate allergen labeling and preventing cross-contamination is paramount. The consequences of a mislabeled product can be severe, leading to recalls, reputational damage, ...

05 03 2025

Serum-free media (SFM) offers numerous advantages in cell culture, including defined composition, reduced variability, and elimination of animal-derived components. However, its application in the Monocyte Activation Test (MAT) presents specific pitfalls that must be carefully considered. Potential ...

05 03 2025

European Pharmacopoeia (EP) chapter 5.1.13 marks a decisive turning point in pyrogen risk assessment, moving beyond the sole detection of bacterial endotoxins (chapter 5.1.10). This new approach, centered on the origin of risk, redefines testing strategies for pharmaceutical products. At the heart of ...

06 03 2025

CellMade's Pyrogen Testing Toolbox: Harnessing bioMérieux's EndoZYME® II GO and ENDOLISA® for a Horseshoe Crab-Friendly Future The landscape of endotoxin testing is undergoing a significant transformation, driven by advancements in biotechnology and a growing emphasis on sustainability. ...

06 03 2025

Food allergies are a growing global health concern, impacting millions of individuals. For those affected, clear and accurate food labeling is crucial, not just for convenience, but to avoid potentially life-threatening reactions. This article provides a comparative analysis of food allergen legislation ...

07 03 2025

The development of biological therapeutics, while offering groundbreaking treatments, carries the inherent risk of pyrogenicity. Pyrogens, substances that induce fever, can trigger severe adverse reactions in patients, ranging from chills and headaches to septic shock. Therefore, meticulous assessment ...

12 05 2025

CellMade®, your trusted independent French expert in food contaminant analysis since 2007, is thrilled to announce its participation in a cutting-edge initiative: the "Allergen quantitation in complex food matrices" project spearheaded by the esteemed Wageningen University. This ambitious ...

22 10 2025

Based on many industry discussions, it's clear there's a misunderstanding about when to apply Good Manufacturing Practices (GMP), especially for analytical methods like the Monocyte Activation Test (MAT). The answer is simpler than you think. The regulatory status isn't determined by the ...