03 03 2025
Mycoplasma contamination remains a significant challenge in pharmaceutical manufacturing, threatening product quality, patient safety, and a company's reputation. These tiny bacteria, lacking a rigid cell wall, can easily infiltrate cell cultures used to produce biopharmaceuticals, often without ...
03 03 2025
The Challenge of Traditional Microbiology: For years, the industry has grappled with the inherent limitations of traditional microbiology testing. The agonizing wait for results, often spanning days or even weeks, has hindered production timelines and delayed critical decision-making. Inconsistent ...
27 02 2025
CellMade® is proud to lead the way in endotoxin and pyrogen detection with our state-of-the-art toolbox, tailored for non-routine projects. Our comprehensive approach covers everything from root cause investigations to alternative testing methods, method development, and product-specific validation. Our ...
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 safety is a paramount concern for consumers and producers alike. Ensuring the integrity of the food supply chain requires a comprehensive approach to testing, encompassing all stages of production from farm to fork. Contamination can occur at any point along this journey, making rigorous testing ...
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 ...
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