Understanding and Overcoming of LER (low endotoxin recovery) in Pharmaceutical Formulations.

3/17/2021 14:05 - 14:40

  • Understanding and overcoming of LER (low endotoxin recovery) in pharmaceutical formulations‘ by Klaus Brandenburg
  • LPS (endotoxin) contamination of pharmaceutical drug products according to FDA and  others must be excluded due to the strong ability of LPS to induce inflammation in humans
  • LPS spiking of the formulations frequently shows a loss of measurable LPS (´masking`)  in particular by the Limulus assay.
  • The reason for this observation can be assigned to a conformational change of the LPS aggregates
  • Possibilities are presented with respect to a prevention of the LER by changing the composition of the formulations.

Klaus Brandenburg, CSO of Brandenburg Antiinfektiva, , Forschungszentrum Borstel