Cellular product manufacturers, and especially sterile drug manufacturers, must analyze the injectable products they produce for bacterial endotoxin before releasing them for use in humans or animals. The fact that the product to be released is not above a certain endotoxin level, high fever that may be created in the recipient, etc. It is critical to avoid side effects. Gram-negative bacteria contain an extra layer within the cell wall structure, called the outer membrane, in addition to the peptidoglycan layer. Endotoxin is a component of this outer membrane. Endotoxin has a complex lipopolysaccharide (LPS) structure. Endotoxin size is approximately 10 kDa-1,000kDa. Endotoxins are a kind of last weapon of gram-negative bacteria. This antigenic structure is detected by the Limulus Amebocyte Lysate test, which is a highly sensitive test. In this test, blood from the horseshoe crab is used, even a very small amount of lipopolysaccharide (endotoxin) causes clotting of the limulus lysate, thanks to an amplification caused by an enzyme cascade. This coagulation is detected as gelation.

Our test sensitivity is 0.25EU/ml and 0.03/ml.

Analysis is carried out in our GMP laboratory using the Gel Clot method in accordance with the current European Pharmacopoeia 2.6.14.

Once the product is analyzed, it is finalized and reported within 72 hours.

You can use the following communication channels for detailed information and planning.

Specialist Bioengineering. Yesim Erdogan
E-mail: yesim@dokubiyoteknoloji.com
Tel: 05301276494