whitepaper
Scientific Poster: Development of cGMP-Ready purification process for advenovirus purification
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics...
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Microbiology
whitepaper
Scientific Poster: From Screening to Small Scale GMP Biomanufacturing: Exploring a simple, unified platform strategy for handling a range of cell culture needs
This poster discusses a process for a 12-week clone development process. The process starts in silico, and progresses through screening and clone selection in 96-deepwell plates up to five liter shaker flasks...
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Sensitive new assay detects hepatitis B infection in single liver cells and serum
Technique measuring the cccDNA marker may allow earlier detection of hepatocellular carcinoma in patients…
news
Development of a quantitative pharmacodynamic assay for apoptosis in fixed tumour tissue
Researchers have developed a highly specific apoptosis assay designed for immunofluorescence microscopy analysis of fixed core needle biopsy specimens...
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Sensitive new assay detects hepatitis B infection in single liver cells and serum
Technique measuring the cccDNA marker may allow earlier detection of hepatocellular carcinoma in patients...
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Microbeads to combat infection show promise in burn wound simulations
A potential alternative to antibiotics, protein-coated beads block bacteria from binding host cells...
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Bacteria therapy shows promise for eczema
Topical treatment with live Roseomonas mucosa was found to be safe for adults and children with atopic dermatitis...
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LC-TEM provides a window into the nanoscale
Researchers create a device that allows more electron beam to pass through liquid samples...
article
Specificity in the recombinant factor C test for endotoxin
Limulus amebocyte lysate (LAL) users, compendial experts and regulators are still orienting themselves to the recombinant factor C (rFC) assay. Changes to compendial standards do not occur overnight and, for now, users willing to change must perform the alternative validation procedure USP .
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The changing environment in pyrogen and endotoxin testing
Pyrogen testing of drug products for parenteral administration is a mandatory task. Regulatory authorities require that each batch of drug product is pyrogen-free. Historically, the rabbit pyrogen test (RPT) was the required test but in most cases can be replaced by the endotoxin specifi c Limulus Amebocyte Lysate (LAL) test.
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The latest trends in pharmaceutical microbiology
There have been many changes in pharmaceutical microbiology as we progressed into the 21st century. Some of these changes have been due to the advance of rapid microbiological methods, knowledge gained from the study of the human microbiome, while others are changes to conventional testing methods. This paper discusses some…
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FDA authorises new use of test to identify the emerging pathogen Candida auris
The FDA has authorised the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalised patients...
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Could statins ease deadly heart condition in rare neuromuscular disease?
Penn study shows that cholesterol drug may help Friedreich's ataxia patients...
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Microbiology In-Depth Focus 2018
In this In-Depth Focus; specificity in the recombinant factor C test for endotoxin, the latest trends in pharmaceutical microbiology, and the changing environment in pyrogen and endotoxin testing.
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Issue #2 2018 – Digital Version
In this issue; recent developments in turning promising compounds into drug candidates, reviewing the latest trends in pharmaceutical microbiology and their implications, and a roundtable debate featuring the views of five industry leaders.
