In the arsenal of approved small molecule drugs, effective, genetically-targeted therapies for the treatment of autoimmune diseases are conspicuously scarce. ImmunoMolecular Therapeutics (IM Therapeutics) has developed a paradigm for the discovery and development of new molecular entities as a broad platform for blocking genetic targets that confer risk of disease development…
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12 April 2021 | By Charles River Laboratories
Join Jordi Iglesias on 1 June at 15:00 BST, as he summarises the ICH Q9 Quality risk management GMP document and explains how you can use the approach and tools described to proactively improve your microbiological QC assays in terms of data integrity.
The PCR based Alinity™ m Resp-4-Plex molecular assay can detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV).
Improved in vitro renal tubular drug transport modelling to meet regulatory and development cost challenges
Due to the high costs associated with drug discovery and the clinical demand for effective drugs, in vitro human cell-based kidney models using renal proximal tubule epithelia are becoming popular tools for early-stage testing. It is increasingly more important that in vitro models of renal drug transport are physiologically representative…
Rising at a CAGR of 4.5 percent, the lateral flow assays market is projected increase due to the high prevalence of infectious diseases worldwide.
Expert view: The right endotoxin detection solution for you – bioMérieux’s complete portfolio of rFC endotoxin assays
As part of any general pyrogen testing strategy, the detection of even minute traces of the highly pyrogenic bacterial molecule called lipopolysaccharide (LPS, also named endotoxin) in pharmaceutical samples is mandatory to ensure patient safety.
Researchers have demonstrated that bioavailability tests in patients to reveal anti-drug antibody levels could aid personalised medicine.
An initial 450,000 of Oxford Nanopore's LamPORE test will be used by the UK government as COVID-19 diagnostics, which yield results in under two hours.
To fulfil the need for compliant, efficient endotoxin testing that the horseshoe crab population can sustain, SUEZ introduces the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform.
Lonza and Sanquin partner for commercialisation of specialised MAT reagents for accurate and reliable in vitro pyrogen testing
Lonza Sales AG, through its Bioscience Division has joined forces with Sanquin Reagents B.V. to enable drug developers and quality control laboratories to take full advantage of the power of the Monocyte Activation Test (MAT).
THE ADVANTAGES of the recombinant Factor C (rFC) test lie in its (a) scientific characterisation, (b) sustainability and (c) specificity. In light of diminishing horseshoe crab populations, sustainability has been mandated via regulations that include the concept of the “3 Rs”: replacement, reduction and refinement of analytical tests and reagents…
New research suggests the flow cytometry sector will grow at a CAGR of 8.2 percent due to increased adoption and expanding uses.
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.
Characterisation and quality control of proteinbased biotherapeutics has historically been a lengthy and challenging process due to their complexity and inherent heterogeneity.