Reduced Endotoxin Levels - GMP Cytokines

August 2016

Improve the safety and reproducibility of your T cell Therapy

In response to an increasing demand for low endotoxin cytokines, we have adapted our test method to be able to measure lower endotoxin threshold values. With this revalidated testing procedure we were able to demonstrate that the residual endotoxin content of all our GMP grade cytokines is consistently lower than previously specified at <1000 EU/mg. We now offer GMP grade cytokines with endotoxin threshold values as low as ≤25 EU/mg and ≤50 EU/mg.

Certain ex vivo cell culture protocols, such as T cell expansion, require particularly low residual endotoxin levels. To make sure that endotoxin will not influence the activation, metabolism and inhibition of T cells, we have revalidated our endotoxin test procedure for our T cell cytokines. We are now able to detect endotoxin values of ≤25 EU/mg for our GMP grade and preclinical IL-2, IL-7, IL-15 and IL-21. Our data show that all batches for GMP grade IL-2, IL-7 and IL-21 consistently meet these new specifications. For our GMP grade IL-15 we have improved our purification procedure to meet this lower endotoxin level. 

Safe GMP Compliant Reliable