BACTERIAL ENDOTOXIN TEST VALIDATION FOR PEGYLATED RECOMBINANT HUMAN GRANULOCYTE COLONY STIMULATING FACTOR: A CASE STUDY

Recombinant human granulocyte colony stimulating factor (rHu GCSF) injection is used to increase the neutrophil production after chemotherapy. Various strategies have been tried to increase the half life of rHu GCSF and of these, pegylation is commonly used. Bacterial Endotoxin Test (BET) is an important quality control test for release of biotherapeutic drugs for human use. Although, pharmacopoeia details the endotoxin test for rHu GCSF, no such monograph is available for pegylated rHu GCSF. Hence, the study was conducted to establish and validate the Limulus Amebocyte Lysate (LAL) gel clot limit test method as an end product endotoxin test for pegylated rHu GCSF. The results suggest that quantification of endotoxin in pegylated rHu GCSF can be performed by LAL gel clot limit test method and the method is unaffected by presence of modified rHu GCSF.