The recombinant Factor C (rFC) assay has been developed to help alleviate the pressures of a growing demand for the Limulus amoebocyte lysate (LAL) assay. Here, Sven Deutschmann and Johannes Reich discuss the advantages of rFC and its recent recognition by the European Pharmacopoeia as an alternative endotoxin test.
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Characterisation and quality control of proteinbased biotherapeutics has historically been a lengthy and challenging process due to their complexity and inherent heterogeneity.
Purification of a drug from host cell protein contaminants can be challenging, with low-level contamination often remaining after purification. Vanda Dolabela de Magalhães shares discussions on the subject from six Brazilian companies working in the biotech field.
This whitepaper demonstrates the High Performance Liquid Chromatography (HPLC) separation and analysis technique and highlights the importance of using water of sufficient purity as an eluent and how the arium® pro VF system can facilitate this.
As the pioneers of the Limulus amebocyte lysate (LAL) testing methodology, Associates of Cape Cod, Inc. (ACC), specialises in bacterial endotoxin and (1→3)-ß-D-glucan detection, using FDA-licensed chromogenic, turbidimetric and gel-clot reagent technologies.
Those who work in QC know that the job is more than a box to be checked, and that it can’t be done effectively without confidence in the reported results. Tight timelines, regulatory demands, and stringent data integrity standards can make it hard to focus on what’s really at stake…
Emerging recombinant Factor C (rFC) methods have many advantages to offer pharmaceutical quality control, including improved specificity, robustness, efficiency and alignment with 3R principles. First, global manufacturers have validated rFC and pharmacopoeias worldwide are on the move. Here, Karolina Heed provides an industry and regulatory update.
The Monocyte Activation Test (MAT) is used to detect or quantify pyrogenic substances that activate human monocytes.
Product Hub: High sensitivity pyrogen testing with the PyroMAT™ system: make the move to the next MAT generation
Used to detect a broad range of pyrogens in parenteral products including pharmaceuticals, biopharmaceuticals and medical devices, the Monocyte Activation Test (MAT) gives an in vitro alternative to conventional animal testing in accordance with regulatory guidelines.
Karolina Heed from the endotoxin unit Hyglos at bioMérieux introducing rapid ENDOZYME® II GO, the latest member of bioMérieux’s ENDONEXT™️ range of endotoxin detection assays based on sustainable recombinant horseshoe crab Factor C (rFC).
Eurofins BioPharma Product Testing expands its footprint of GMP testing laboratories with recent acquisitions, including Astellas Analytical Science Laboratories, Inc. (ASL) in Japan, PHAST Gesellschaft für Pharmazeutische Qualitätsstandards mbH (PHAST) in Germany, and Bactup in France...
Oligonucleotides must be of high purity when used in molecular biology applications, but efficient purification over a large range of production scales is challenging. The Gilson GX-271 Oligonucleotide Purification System provides a versatile solution for continuous separation, analysis, and desalting of oligonucleotides...
Wickham Laboratories draws on deep technical expertise, backed by decades of global experience, when identifying challenges and providing solutions for a broad range of products and testing scenarios.