In modern biopharmaceutical manufacturing, maintaining stringent quality control (QC) for parenteral drug products is essential to ensuring product safety and regulatory compliance. Parenteral ...

In the highly regulated fields of pharmaceutical, bio-pharmaceuticals, medical devices, and clinical diagnostics, bacterial endotoxin testing (BET) remains a critical requirement for safeguarding ...

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, ...

Understanding the relative strengths and weaknesses of different endotoxin test methods is crucial to maintaining quality and patient safety. Endotoxins are small, hydrophobic molecules that are part ...

The alternative text for this image may have been generated using AI. Endotoxin tolerance is the situation in which previous exposure to a low level of lipopolysaccharide (LPS) induces a transient ...

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 ...

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.

CHICAGO -- Blood purification using polymyxin B showed a mortality reduction signal in patients with septic shock and high endotoxin activity, researchers reported here. In the phase III Tigris trial, ...

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 ...