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This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
The contamination of pharmaceuticals by microorganisms represents a major threat to public health, not just in the USA and Europe, but all around the world. Pathogenic microorganisms cause morbidity and in some cases mortality when present in products.1,2 Spoilage due to microbial breakdown of formulations can affect potency and shelf…
The Burkholderia cepacia complex (BCC) species are a group of gram-negative, rod-shaped bacteria that have been shown in recent years to be of concern for patients, and thus for manufacturers of drugs and products that contribute to patient health...
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics...
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...
In this issue: Microfluidics technology in pharmaceutical research, drug manufacturing and development, and is supercritical fluid chromatography applicable to achiral separations?
The concept of developing a bioink that can be used for all cell types and all printing techniques is at best unrealistic and at worst impossible. What is much more achievable and also more desirable is a modifiable, modular system...
A new technology could allow researchers to fit more biochemical probes onto a single biochip and reduce the cost of screening and analyzing changes associated with disease development...
The European Pharmacopoeia chapter on methods for microbiological quality control was recently revised to include a number of significant changes. In this In-Depth Focus Michael Miller provides the first part of this two-part review and Kevin Williams discusses a paradigm change in biologics microbiological contaminant control.
In this issue: Sample preparation - is it possible to have too much? Developing successful over-the-counter syrup packaging for the highly regulated EU market. In-line process PAT in continous wet granulation, and much more...
