Articles in this Issue
Mick Dawson, Brett Hoffmeister
A number of recently published articles and reports contained information that is inaccurate regarding the horseshoe crab population and its use in the biomedical industry.
Mark Kapeckas, Marine Marius, Jon Williams
Low Endotoxin Recovery (LER) has been THE hot industry topic for many years now and still there are debates on some fundamental points. Fortunately, the collective eff orts of regulatory authorities, biopharma manufacturers, industry groups, as well as instrument and reagent vendors have provided a much clearer direction over the last five years.
Karen Zink McCullough
Analysts working on Bacterial Endotoxins Test (BET) method development are often presented with new compounds or new products, and are asked to calculate an endotoxin limit, develop a test method for the new material and transfer the validated test method to QC. What is an endotoxin limit and what information do Assay Developers need to know in order to calculate one?
Health Authority regulations require that parenteral drug products must be non-pyrogenic. Endotoxins or lipopolysaccharides (LPS) are the most likely source of pyrogenic drug product contamination due to their ubiquity and high pyrogenic potency compared to other microbial pathogen-associated molecular patterns (PAMP).
Microbial biofilms - structured consortium of bacteria that are embedded in layers of self-produced polymer matrices, largely composed of polysaccharide, protein and DNA – are well described and known problems for pharmaceutical water systems and medical devices. What is less well-researched is the association of biofilms with endotoxin, especially within the pharmaceutical and medical device context.