Pegylated Recombinant Human Erythropoietin

Pegylated Recombinant Human Erythropoietin (Peg-EPO) is a biopharmaceutical agent used in the treatment of anemia. It is designed to mimic the action of endogenous erythropoietin, a hormone naturally produced by specialized kidney cells. Erythropoietin stimulates the production of red blood cells, a process known as erythropoiesis. Peg-EPO is particularly valuable for patients with kidney failure or those undergoing chemotherapy. By extending the circulating half-life of recombinant erythropoietin, it effectively addresses anemia associated with chronic kidney disease and chemotherapy

ICGEB provides end-to-end process transfer for the production of rhEPO, the pegylation reagent and pegylation process.
The pegylation reaction can be performed directly following the purification of rhEPO and the resulting material satisfied European Pharmacopoeia standards.

Following the preparation of rhEPO, the Pegylation Reagent (methoxypolyethylene glycol-butanoic acid succinimidyl ester) is synthesized in a Reaction Batch of 10 grams of the starting methoxypolyethylene glycol material (30 KDa molecular weight). The synthetic crude product is then purified (yield at least 40%) and activated. The succinimidyl ester activity of the final product is tested by RP-HPLC-ELSD after a chemical derivatization and is around 80%.
Pegylation Reaction: Pegylation Reaction Batch is composed of around 30 mg of recombinant human
Erythropoietin (rhEPO) and Pegylation Reagent in controlled conditions of buffer
composition, protein concentration, reagent molar excess, pH, temperature and
time. This corresponds to a batch size of 100 doses and is easily scalable.
1.3 Purification: At the end-point the reaction contains the monopegylated EPO (mPEG-EPO), native EPO and oligomeric forms of pegylated EPO. The mPEG-EPO is purified by
chromatography. The purity of the product is at least 95% by SDS-PAGE (stained
by Coomassie to visualize the protein portion and by Barium/iodine to visualize
the mPEG portion) and RP-HPLC analysis. Final yield of the process is at least 20%
of the EPO used in the pegylation reaction.

Recombinant Human Erythropoietin Beta is used to treat anemia.