Endotoxin Levels Matter: The Importance Of Quality Proteins For Research, Development, And Manufacturing

Developing Advanced Therapy Medicinal Products (ATMPs) requires stringent strategies to prevent contamination from adventitious agents. While sterility is a standard priority, bacterial endotoxins pose a unique, silent threat that can persist even in sterile environments. These lipopolysaccharides, released during bacterial cell lysis, can drastically alter protein expression in cell cultures and compromise manufacturing consistency. More critically, they act as pyrogens, potentially triggering severe inflammatory responses or septic shock in patients.

To meet regulatory expectations from bodies like the EMA and FDA, manufacturers must look beyond end-product testing and rigorously evaluate raw materials—particularly recombinant proteins used during production. Ensuring low endotoxin levels through validated methods like the limulus amebocyte lysate (LAL) assay is essential for safeguarding therapeutic potency and patient safety. Read the full application note to explore specific endotoxin limits and testing strategies for your raw materials.