The World Health Organization (WHO) has published its new 2025 Guidelines on the replacement or removal of animal tests for ...

Endotoxin removal from a finished product is a major challenge for biopharmaceutical manufacturers; particularly as all endotoxin removal methods have operational limitations and may result in loss of ...

In early life, the innate immune system can recognize both viable and nonviable parts of microorganisms. Immune activation may direct the immune response, thus conferring tolerance to allergens such ...

Inadequate endotoxin testing places patients at risk. Knowing the relative strengths and weaknesses of available test methods is crucial to maintaining quality and safety. Endotoxins are small, ...

Surf on a beach at sunset features a horseshoe crab upside down in the water and several others nearby. Regulatory changes may make the pharmaceutical industry less reliant on horseshoe crabs for ...

Endotoxin testing is critical for quality control in drug production, as it has a direct impact on pharmaceutical safety and effectiveness. Traditionally Limulus Amebocyte Lysate (LAL) testing is used ...

Increased vascular permeability contributes to many diseases, including acute respiratory distress syndrome, cancer and inflammation. Most past work on vascular barrier function has focused on soluble ...

Bacteria can be found everywhere—even sometimes in clean rooms. That’s a problem for manufacturers of drugs and medical devices that are injected or implanted. Even if manufacturers can remove the ...

Endotoxin refers to a component of the outer cell membrane of Gram-negative bacteria called lipopolysaccharide (LPS). LPS is the biologically active portion of naturally occurring endotoxin complexes.

Escherichia coli is widely considered the most cost-effective bacterial system for recombinant protein expression. Consequently, it is broadly used. Nonetheless, it has its limitations as an ...

At first, it just didn’t make sense. It was 1963, and a young research fellow at Johns Hopkins medical school was spending the summer on Cape Cod, studying blood coagulation in an animal totally ...