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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 Pyrogen Testing Toolbox offers unparalleled precision, efficiency, and reliability. We've successfully employed the Monocyte Activation Test (MAT) for testing human albumin 20%, navigating complex risks of both endotoxin and non-endotoxin pyrogenic contamination. Our toolbox also offers ...

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 testing. If you're in search of a groundbreaking solution that surpasses traditional methods, your answer lies with CellMade® MAT Testing Services. We harness the power of Monocyte Activation Test (MAT) to provide unparalleled efficiency and precision for your pyrogen testing needs. So, what ...

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, and NGS, CellMade® is setting a new standard for accuracy and sensitivity in allergen detection. Food allergies pose a significant health concern, and ensuring the safety of consumers is paramount. CellMade®'s comprehensive approach to allergen testing utilizes the strengths ...

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 and comprehensive services, including ELISA, Rapid Lateral Flow Strips, High-Purity Mycotoxin Standards, Certified Matrix Reference Materials, and dedicated testing services using ELISA, HPLC, and LC-MS, CellMade® is establishing a new benchmark for accuracy and dependability in mycotoxin analysis. Mycotoxins ...

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, and, most importantly, serious health risks for consumers. To navigate this complex landscape, a multi-tiered approach combining on-site rapid tests with laboratory verification is proving increasingly effective. The Speed and Convenience of On-Site Rapid Tests Rapid test strips, often based ...

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 Pitfalls of Serum-Free Media in MAT: Altered Monocyte Responsiveness: Serum contains essential growth factors, cytokines, and other components that influence monocyte activation. The absence of these factors in SFM can lead to altered monocyte responsiveness, potentially resulting in either ...

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 this revolution, the monocyte activation test (MAT) is emerging as an indispensable method. 1. The MAT: Broadened Applicability Comprehensive Pyrogen Detection: Unlike the BET test, limited to endotoxins, the MAT identifies a broader spectrum of pyrogens, aligning with the comprehensive assessment ...

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. At the forefront of this shift is the increasing adoption of recombinant Factor C (rFC) assays, a trend further accelerated by recent regulatory changes in the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP). The Urgent Need for Sustainable Endotoxin Testing: Protecting ...

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 in the European Union (EU) and the United States (USA), highlighting recent changes and emphasizing the importance of preventing cross-contamination. Core Regulatory Frameworks: EU vs. USA The EU and USA have distinct regulatory approaches to food allergen labeling: EU: Regulation (EU) ...

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 of pyrogenic risk is paramount, particularly during the early stages of development. The Importance of Early Pyrogenicity Assessment Traditional pyrogen testing, like the rabbit pyrogen test (RPT), has limitations in terms of animal welfare, sensitivity, and relevance to human responses. Modern ...

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 activity itself, but by its PURPOSE. Let's break down the MAT lifecycle: BUILDING the Strategy (Managed by the PQS, but NOT GMP Certified) These activities are foundational and scientific. Their purpose is to create and justify the control strategy, not to execute it on a commercial batch. Pyrogenicity ...